Trial Outcomes & Findings for Orbital Vessel PreparaTIon to MaximIZe Dcb Efficacy in Calcified Below the Knee (BTK) Lesions - A Pilot Study (NCT NCT02561299)
NCT ID: NCT02561299
Last Updated: 2023-07-18
Results Overview
Device success was defined as the ability to achieve successful delivery and deployment of the drug-coated balloon (DCB) to the target lesion as described per Instructions for Use (IFU) within 3 minutes of insertion without removal and use of an additional device. The percentage of success was based on the number of DCB devices used.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
66 participants
Primary outcome timeframe
During the procedure
Results posted on
2023-07-18
Participant Flow
Participant milestones
| Measure |
OA With Adjunctive DCB Angioplasty
Lesion preparation with Peripheral Orbital Atherectomy System followed by drug-coated balloon angioplasty
Peripheral Orbital Atherectomy System: Orbital Atherectomy
014 Drug Coated Balloon: Drug Coated Balloon
|
DCB Angioplasty
014 Drug Coated Balloon angioplasty
014 Drug Coated Balloon: Drug Coated Balloon
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
34
|
|
Overall Study
COMPLETED
|
27
|
28
|
|
Overall Study
NOT COMPLETED
|
5
|
6
|
Reasons for withdrawal
| Measure |
OA With Adjunctive DCB Angioplasty
Lesion preparation with Peripheral Orbital Atherectomy System followed by drug-coated balloon angioplasty
Peripheral Orbital Atherectomy System: Orbital Atherectomy
014 Drug Coated Balloon: Drug Coated Balloon
|
DCB Angioplasty
014 Drug Coated Balloon angioplasty
014 Drug Coated Balloon: Drug Coated Balloon
|
|---|---|---|
|
Overall Study
Death
|
2
|
4
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
OA With Adjunctive DCB Angioplasty
n=32 Participants
Lesion preparation with Peripheral Orbital Atherectomy System followed by drug-coated balloon angioplasty
Peripheral Orbital Atherectomy System: Orbital Atherectomy
014 Drug Coated Balloon: Drug Coated Balloon
|
DCB Angioplasty
n=34 Participants
014 Drug Coated Balloon angioplasty
014 Drug Coated Balloon: Drug Coated Balloon
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
73.4 years
STANDARD_DEVIATION 8.5 • n=32 Participants
|
76.5 years
STANDARD_DEVIATION 7.1 • n=34 Participants
|
75.0 years
STANDARD_DEVIATION 7.9 • n=66 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=32 Participants
|
9 Participants
n=34 Participants
|
15 Participants
n=66 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=32 Participants
|
25 Participants
n=34 Participants
|
51 Participants
n=66 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Rutherford Clinical Category
Severe Claudication (3)
|
10 Participants
n=32 Participants
|
8 Participants
n=34 Participants
|
18 Participants
n=66 Participants
|
|
Rutherford Clinical Category
Ischemic Rest Pain (4)
|
2 Participants
n=32 Participants
|
4 Participants
n=34 Participants
|
6 Participants
n=66 Participants
|
|
Rutherford Clinical Category
Minor Tissue Loss (5)
|
20 Participants
n=32 Participants
|
22 Participants
n=34 Participants
|
42 Participants
n=66 Participants
|
PRIMARY outcome
Timeframe: During the procedureDevice success was defined as the ability to achieve successful delivery and deployment of the drug-coated balloon (DCB) to the target lesion as described per Instructions for Use (IFU) within 3 minutes of insertion without removal and use of an additional device. The percentage of success was based on the number of DCB devices used.
Outcome measures
| Measure |
OA With Adjunctive DCB Angioplasty
n=45 Drug Coated Balloons
Lesion preparation with Peripheral Orbital Atherectomy System followed by drug-coated balloon angioplasty
Peripheral Orbital Atherectomy System: Orbital Atherectomy
014 Drug Coated Balloon: Drug Coated Balloon
|
DCB Angioplasty
n=48 Drug Coated Balloons
014 Drug Coated Balloon angioplasty
014 Drug Coated Balloon: Drug Coated Balloon
|
|---|---|---|
|
Device Success
|
42 Drug Coated Balloons
|
39 Drug Coated Balloons
|
PRIMARY outcome
Timeframe: 6 months and 12 months post-procedurePopulation: Lesions with available data for patency assessment by the DUS Core Lab
Patency of the target lesion as reported by the Duplex Ultrasound (DUS) Core Laboratory. Vessel patency at 6 months and 12 months by Duplex Ultrasound (DUS), where patency is defined as \<50% restenosis within the treated lesion area. Patency was assessed by the DUS Core Laboratory.
Outcome measures
| Measure |
OA With Adjunctive DCB Angioplasty
n=35 Lesions
Lesion preparation with Peripheral Orbital Atherectomy System followed by drug-coated balloon angioplasty
Peripheral Orbital Atherectomy System: Orbital Atherectomy
014 Drug Coated Balloon: Drug Coated Balloon
|
DCB Angioplasty
n=37 Lesions
014 Drug Coated Balloon angioplasty
014 Drug Coated Balloon: Drug Coated Balloon
|
|---|---|---|
|
Patency of the Target Lesion at 6 Months and 12 Months Post-Procedure
Patency at 6 months
|
15 Lesions
|
5 Lesions
|
|
Patency of the Target Lesion at 6 Months and 12 Months Post-Procedure
Patency at 12 months
|
15 Lesions
|
6 Lesions
|
PRIMARY outcome
Timeframe: 6 months and 12 months post-procedureA Kaplan-Meier analysis was performed to determine the percent probability that a study participant was free from CD-TLR through 6 months and 12 months.
Outcome measures
| Measure |
OA With Adjunctive DCB Angioplasty
n=32 Participants
Lesion preparation with Peripheral Orbital Atherectomy System followed by drug-coated balloon angioplasty
Peripheral Orbital Atherectomy System: Orbital Atherectomy
014 Drug Coated Balloon: Drug Coated Balloon
|
DCB Angioplasty
n=34 Participants
014 Drug Coated Balloon angioplasty
014 Drug Coated Balloon: Drug Coated Balloon
|
|---|---|---|
|
Freedom From Clinically-Driven Target Lesion Revascularization (CD-TLR) at 6 Months and 12 Months Post-Procedure
Freedom from CD-TLR at 6 months
|
96.8 % probability
Interval 90.6 to 103.0
|
94.1 % probability
Interval 86.2 to 102.0
|
|
Freedom From Clinically-Driven Target Lesion Revascularization (CD-TLR) at 6 Months and 12 Months Post-Procedure
Freedom from CD-TLR at 12 months
|
86.4 % probability
Interval 74.0 to 98.8
|
91.0 % probability
Interval 81.2 to 100.7
|
PRIMARY outcome
Timeframe: 6 months and 12 months post-procedureA Kaplan-Meier analysis was performed to determine the percent probability that the study participant was free from an unplanned, unavoidable major amputation of the index limb through 6 months and 12 months.
Outcome measures
| Measure |
OA With Adjunctive DCB Angioplasty
n=32 Participants
Lesion preparation with Peripheral Orbital Atherectomy System followed by drug-coated balloon angioplasty
Peripheral Orbital Atherectomy System: Orbital Atherectomy
014 Drug Coated Balloon: Drug Coated Balloon
|
DCB Angioplasty
n=34 Participants
014 Drug Coated Balloon angioplasty
014 Drug Coated Balloon: Drug Coated Balloon
|
|---|---|---|
|
Freedom From Unplanned, Unavoidable Major Amputation of the Index Limb at 6 Months and 12 Months Post-Procedure
Freedom from major amputation at 6 months
|
100.0 % probability
Interval 100.0 to 100.0
|
100.0 % probability
Interval 100.0 to 100.0
|
|
Freedom From Unplanned, Unavoidable Major Amputation of the Index Limb at 6 Months and 12 Months Post-Procedure
Freedom from major amputation at 12 months
|
96.6 % probability
Interval 89.9 to 103.2
|
100.0 % probability
Interval 100.0 to 100.0
|
PRIMARY outcome
Timeframe: 6 months and 12 months post-procedureA Kaplan-Meier analysis was performed to determine the percent probability that the study participant was free from a major adverse event (MAE) through 6 months and 12 months. Major adverse events were defined as: clinically-driven target lesion revascularization (CD-TLR); unplanned, unavoidable major amputation of the index limb; and death within 30 days of the index procedure.
Outcome measures
| Measure |
OA With Adjunctive DCB Angioplasty
n=32 Participants
Lesion preparation with Peripheral Orbital Atherectomy System followed by drug-coated balloon angioplasty
Peripheral Orbital Atherectomy System: Orbital Atherectomy
014 Drug Coated Balloon: Drug Coated Balloon
|
DCB Angioplasty
n=34 Participants
014 Drug Coated Balloon angioplasty
014 Drug Coated Balloon: Drug Coated Balloon
|
|---|---|---|
|
Freedom From Major Adverse Events (MAEs) at 6 Months and 12 Months Post-Procedure
Freedom from MAE at 6 months
|
90.6 % probability
Interval 80.5 to 100.7
|
91.2 % probability
Interval 81.6 to 100.7
|
|
Freedom From Major Adverse Events (MAEs) at 6 Months and 12 Months Post-Procedure
Freedom from MAE at 12 months
|
77.7 % probability
Interval 63.1 to 92.3
|
85.3 % probability
Interval 73.4 to 97.2
|
PRIMARY outcome
Timeframe: Baseline, 6 months and 12 months post-procedurePopulation: The number of participants analyzed at 6 and 12 months differs from the overall number due to missing data.
Rutherford Classification (RC) is a commonly used clinical grading system for describing peripheral arterial disease (PAD) on a scale of 0 to 6. RC 6 is the most severe form of PAD. There are seven Rutherford categories used to grade the severity of peripheral artery disease; 0: asymptomatic, 1: mild claudication, 2: moderate claudication, 3: severe claudication, 4: ischemic rest pain, 5: minor tissue loss, 6: major tissue loss. The change in Rutherford category is presented as the distribution at baseline compared to that at 6- and 12-months post-procedure.
Outcome measures
| Measure |
OA With Adjunctive DCB Angioplasty
n=32 Participants
Lesion preparation with Peripheral Orbital Atherectomy System followed by drug-coated balloon angioplasty
Peripheral Orbital Atherectomy System: Orbital Atherectomy
014 Drug Coated Balloon: Drug Coated Balloon
|
DCB Angioplasty
n=34 Participants
014 Drug Coated Balloon angioplasty
014 Drug Coated Balloon: Drug Coated Balloon
|
|---|---|---|
|
Change in Rutherford Category at 6 Months and 12 Months Post-Procedure
Baseline · Rutherford Category 0
|
0 Participants
|
0 Participants
|
|
Change in Rutherford Category at 6 Months and 12 Months Post-Procedure
Baseline · Rutherford Category 4
|
2 Participants
|
4 Participants
|
|
Change in Rutherford Category at 6 Months and 12 Months Post-Procedure
6 months · Rutherford Category 2
|
2 Participants
|
0 Participants
|
|
Change in Rutherford Category at 6 Months and 12 Months Post-Procedure
12 months · Rutherford Category 5
|
5 Participants
|
5 Participants
|
|
Change in Rutherford Category at 6 Months and 12 Months Post-Procedure
12 months · Rutherford Category 6
|
0 Participants
|
0 Participants
|
|
Change in Rutherford Category at 6 Months and 12 Months Post-Procedure
12 months · Rutherford Category 0
|
10 Participants
|
8 Participants
|
|
Change in Rutherford Category at 6 Months and 12 Months Post-Procedure
Baseline · Rutherford Category 1
|
0 Participants
|
0 Participants
|
|
Change in Rutherford Category at 6 Months and 12 Months Post-Procedure
Baseline · Rutherford Category 2
|
0 Participants
|
0 Participants
|
|
Change in Rutherford Category at 6 Months and 12 Months Post-Procedure
Baseline · Rutherford Category 3
|
10 Participants
|
8 Participants
|
|
Change in Rutherford Category at 6 Months and 12 Months Post-Procedure
Baseline · Rutherford Category 5
|
20 Participants
|
22 Participants
|
|
Change in Rutherford Category at 6 Months and 12 Months Post-Procedure
Baseline · Rutherford Category 6
|
0 Participants
|
0 Participants
|
|
Change in Rutherford Category at 6 Months and 12 Months Post-Procedure
6 months · Rutherford Category 0
|
6 Participants
|
7 Participants
|
|
Change in Rutherford Category at 6 Months and 12 Months Post-Procedure
6 months · Rutherford Category 1
|
5 Participants
|
1 Participants
|
|
Change in Rutherford Category at 6 Months and 12 Months Post-Procedure
6 months · Rutherford Category 3
|
1 Participants
|
1 Participants
|
|
Change in Rutherford Category at 6 Months and 12 Months Post-Procedure
6 months · Rutherford Category 4
|
0 Participants
|
0 Participants
|
|
Change in Rutherford Category at 6 Months and 12 Months Post-Procedure
6 months · Rutherford Category 5
|
8 Participants
|
8 Participants
|
|
Change in Rutherford Category at 6 Months and 12 Months Post-Procedure
6 months · Rutherford Category 6
|
0 Participants
|
0 Participants
|
|
Change in Rutherford Category at 6 Months and 12 Months Post-Procedure
12 months · Rutherford Category 1
|
3 Participants
|
3 Participants
|
|
Change in Rutherford Category at 6 Months and 12 Months Post-Procedure
12 months · Rutherford Category 2
|
2 Participants
|
1 Participants
|
|
Change in Rutherford Category at 6 Months and 12 Months Post-Procedure
12 months · Rutherford Category 3
|
4 Participants
|
1 Participants
|
|
Change in Rutherford Category at 6 Months and 12 Months Post-Procedure
12 months · Rutherford Category 4
|
0 Participants
|
0 Participants
|
Adverse Events
OA With Adjunctive DCB Angioplasty
Serious events: 29 serious events
Other events: 4 other events
Deaths: 2 deaths
DCB Angioplasty
Serious events: 22 serious events
Other events: 2 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
OA With Adjunctive DCB Angioplasty
n=32 participants at risk
Lesion preparation with Peripheral Orbital Atherectomy System followed by drug-coated balloon angioplasty
Peripheral Orbital Atherectomy System: Orbital Atherectomy
014 Drug Coated Balloon: Drug Coated Balloon
|
DCB Angioplasty
n=34 participants at risk
014 Drug Coated Balloon angioplasty
014 Drug Coated Balloon: Drug Coated Balloon
|
|---|---|---|
|
Cardiac disorders
Angina Pectoris (Ischemic Chest Pain)
|
0.00%
0/32 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
2.9%
1/34 • Number of events 1 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
|
Cardiac disorders
Arrhythmias
|
0.00%
0/32 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
5.9%
2/34 • Number of events 2 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
|
Cardiac disorders
Cardiac/Cardiopulmonary Arrest
|
0.00%
0/32 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
2.9%
1/34 • Number of events 1 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
|
Cardiac disorders
Cardiac Dysfunction-Acute Heart Failure
|
3.1%
1/32 • Number of events 1 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
2.9%
1/34 • Number of events 1 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
|
Cardiac disorders
Cardiac Dysfunction-Chronic Heart Failure or Aggravated
|
6.2%
2/32 • Number of events 3 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
14.7%
5/34 • Number of events 5 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
|
Cardiac disorders
Cardiac Valve Disorders
|
3.1%
1/32 • Number of events 1 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
2.9%
1/34 • Number of events 1 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
|
Cardiac disorders
Coronary Artery Stenosis
|
6.2%
2/32 • Number of events 2 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
0.00%
0/34 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
|
Cardiac disorders
Myocardial Infarction
|
12.5%
4/32 • Number of events 4 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
0.00%
0/34 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
|
Cardiac disorders
Cardiac-Other
|
3.1%
1/32 • Number of events 1 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
0.00%
0/34 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
|
Vascular disorders
New/Worsening Infection
|
31.2%
10/32 • Number of events 16 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
14.7%
5/34 • Number of events 10 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
|
Vascular disorders
New/Worsening Pain
|
18.8%
6/32 • Number of events 7 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
5.9%
2/34 • Number of events 2 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
|
Vascular disorders
New/Worsening Wound
|
25.0%
8/32 • Number of events 17 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
23.5%
8/34 • Number of events 13 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
|
Vascular disorders
Peripheral Artery Restenosis
|
12.5%
4/32 • Number of events 6 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
17.6%
6/34 • Number of events 9 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
|
Vascular disorders
Peripheral Artery Stenosis
|
15.6%
5/32 • Number of events 6 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
23.5%
8/34 • Number of events 9 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
|
Vascular disorders
Peripheral Thrombus/Thrombosis
|
3.1%
1/32 • Number of events 1 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
0.00%
0/34 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
|
Injury, poisoning and procedural complications
Peripheral Artery Aneurysm
|
0.00%
0/32 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
2.9%
1/34 • Number of events 1 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
|
Injury, poisoning and procedural complications
Peripheral Artery Psedoaneurysm
|
3.1%
1/32 • Number of events 1 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
0.00%
0/34 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
|
Injury, poisoning and procedural complications
Peripheral Artery Thrombus/Thrombosis
|
0.00%
0/32 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
2.9%
1/34 • Number of events 1 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
|
Vascular disorders
Bleeding/Hemorrhage,Access Site
|
3.1%
1/32 • Number of events 1 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
0.00%
0/34 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
|
Vascular disorders
Bleeding/Hemorrhage, Non Access Site
|
6.2%
2/32 • Number of events 2 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
0.00%
0/34 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
|
Vascular disorders
Carotid Artery Disease
|
0.00%
0/32 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
2.9%
1/34 • Number of events 1 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
|
Vascular disorders
Hypertension
|
3.1%
1/32 • Number of events 2 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
2.9%
1/34 • Number of events 2 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
|
Gastrointestinal disorders
Gastrointestinal Infection/Inflammation
|
3.1%
1/32 • Number of events 1 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
2.9%
1/34 • Number of events 1 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
|
Gastrointestinal disorders
Hemorrhoids
|
3.1%
1/32 • Number of events 1 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
0.00%
0/34 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
|
Hepatobiliary disorders
Hepatic/Biliary System Disorders (e.g liver, bile duct)
|
0.00%
0/32 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
2.9%
1/34 • Number of events 1 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
|
Gastrointestinal disorders
Digestive Disorders-Other
|
3.1%
1/32 • Number of events 1 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
5.9%
2/34 • Number of events 2 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
|
Psychiatric disorders
Chronic Mental Illness (e.g. anxiety, depression)
|
3.1%
1/32 • Number of events 1 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
0.00%
0/34 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
|
Nervous system disorders
Intracranial Hemorrhage
|
3.1%
1/32 • Number of events 1 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
0.00%
0/34 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
|
Nervous system disorders
Stroke
|
12.5%
4/32 • Number of events 4 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
0.00%
0/34 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
|
Nervous system disorders
Syncope/Loss of Consciousness
|
6.2%
2/32 • Number of events 2 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
2.9%
1/34 • Number of events 1 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
|
Renal and urinary disorders
Acute Renal Failure
|
3.1%
1/32 • Number of events 2 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
2.9%
1/34 • Number of events 1 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
|
Renal and urinary disorders
Chronic Renal Failure or Worsened
|
3.1%
1/32 • Number of events 1 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
0.00%
0/34 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
|
Renal and urinary disorders
Urinary Tract Infection (UTI)
|
9.4%
3/32 • Number of events 3 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
2.9%
1/34 • Number of events 2 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease (COPD)
|
0.00%
0/32 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
2.9%
1/34 • Number of events 4 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/32 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
2.9%
1/34 • Number of events 1 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
6.2%
2/32 • Number of events 3 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
5.9%
2/34 • Number of events 3 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
3.1%
1/32 • Number of events 1 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
0.00%
0/34 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Tract Infection
|
0.00%
0/32 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
2.9%
1/34 • Number of events 1 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory/Thoracic Disorders-Other
|
0.00%
0/32 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
5.9%
2/34 • Number of events 3 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
|
General disorders
Blood and Lymphatic System Disorder-Anemia
|
3.1%
1/32 • Number of events 1 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
2.9%
1/34 • Number of events 1 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
|
General disorders
Blood and Lymphatic System Disorders-Other
|
0.00%
0/32 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
2.9%
1/34 • Number of events 1 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
|
General disorders
Cancer
|
3.1%
1/32 • Number of events 1 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
5.9%
2/34 • Number of events 3 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
|
General disorders
Chest Pain, Non-Cardiac
|
0.00%
0/32 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
2.9%
1/34 • Number of events 1 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
|
General disorders
Chest Pain, Unspecified
|
3.1%
1/32 • Number of events 1 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
0.00%
0/34 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
|
General disorders
Endocrine/Metabolic Disorders
|
3.1%
1/32 • Number of events 2 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
5.9%
2/34 • Number of events 2 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
|
General disorders
Infection-Other-Localized
|
3.1%
1/32 • Number of events 1 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
2.9%
1/34 • Number of events 1 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
|
General disorders
Infection-Systemic
|
6.2%
2/32 • Number of events 3 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
2.9%
1/34 • Number of events 1 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
|
General disorders
Injury/Trauma
|
9.4%
3/32 • Number of events 3 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
11.8%
4/34 • Number of events 4 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
|
General disorders
Multi-Organ Failure
|
0.00%
0/32 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
5.9%
2/34 • Number of events 2 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
|
General disorders
Pain-Other
|
0.00%
0/32 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
2.9%
1/34 • Number of events 1 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
|
General disorders
Perhipheral Edema
|
0.00%
0/32 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
2.9%
1/34 • Number of events 1 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
|
General disorders
Shock
|
3.1%
1/32 • Number of events 1 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
0.00%
0/34 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
|
General disorders
Sleep Disorders
|
0.00%
0/32 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
2.9%
1/34 • Number of events 1 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
|
General disorders
Adverse Event-Other
|
0.00%
0/32 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
2.9%
1/34 • Number of events 2 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
Other adverse events
| Measure |
OA With Adjunctive DCB Angioplasty
n=32 participants at risk
Lesion preparation with Peripheral Orbital Atherectomy System followed by drug-coated balloon angioplasty
Peripheral Orbital Atherectomy System: Orbital Atherectomy
014 Drug Coated Balloon: Drug Coated Balloon
|
DCB Angioplasty
n=34 participants at risk
014 Drug Coated Balloon angioplasty
014 Drug Coated Balloon: Drug Coated Balloon
|
|---|---|---|
|
Injury, poisoning and procedural complications
Peripheral Artery Perforation
|
6.2%
2/32 • Number of events 2 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
0.00%
0/34 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
|
Injury, poisoning and procedural complications
Peripheral Artery Thrombus/Thrombosis
|
6.2%
2/32 • Number of events 2 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
0.00%
0/34 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
|
General disorders
Blood and Lymphatic System Disorder-Anemia
|
0.00%
0/32 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
5.9%
2/34 • Number of events 2 • Adverse events were collected from the time of randomization through subject trial completion, up to 24 months.
All serious adverse events were collected throughout the subject participation in the trial. Procedural complications were considered adverse events and were collected from randomization through discharge. Per the protocol, the Core Lab's final classification of endpoint events including Severe Dissection, Perforation, Distal Embolization, and Slow Flow/No Reflow is used for reporting purposes and may differ in classification from site reported adverse events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60