Trial Outcomes & Findings for Real-World Registry Assessing the Clinical Use of the Lutonix 035 Drug Coated Balloon Catheter (NCT NCT02424383)
NCT ID: NCT02424383
Last Updated: 2020-05-22
Results Overview
TLR is defined as the first revascularization procedure (e.g. Percutaneous Transluminal Angioplasty (PTA), stenting, etc.) of the target lesion after the index procedure.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1005 participants
Primary outcome timeframe
12 months post-index procedure
Results posted on
2020-05-22
Participant Flow
Overall, 1005 subjects were enrolled and treated with the study device. A total of 966 subjects were included in the Per-Protocol population (excludes subjects with major protocol deviations) for final analysis.
Between 2015 and 2017, Investigators treated 1005 subjects with the study device. Due to major protocol deviations, 39 subjects were excluded from the analyses conducted in this study. Therefore, the Per-Protocol population included 966 subjects and all outcome results and baseline data are based on this Per-Protocol population.
Participant milestones
| Measure |
PTA (Lutonix® 035 DCB Catheter)
Treatment with the Lutonix 035 DCB will be per the investigational site's standard of care and adhering to the IFU.
PTA (Lutonix® 035 DCB Catheter): Percutaneous Transluminal Angioplasty (PTA) will involve the insertion of a catheter into one of the femoral arteries. Once the catheter is in place, a tiny balloon on the end of the catheter will be inflated to press against the narrowing (or blockage) in the artery to try to open the blockage, and allow more blood to flow through the artery. The balloon may need to be inflated several times in order for the narrowed area to open up sufficiently to improve the blood flow. The area will be viewed with specialized x-ray or other imaging devices to see if the artery has opened enough.
The Lutonix® DCB through the blood vessel to the narrowed area to be treated.
|
|---|---|
|
Overall Study
STARTED
|
1005
|
|
Overall Study
Per-Protocol Population
|
966
|
|
Overall Study
COMPLETED
|
629
|
|
Overall Study
NOT COMPLETED
|
376
|
Reasons for withdrawal
| Measure |
PTA (Lutonix® 035 DCB Catheter)
Treatment with the Lutonix 035 DCB will be per the investigational site's standard of care and adhering to the IFU.
PTA (Lutonix® 035 DCB Catheter): Percutaneous Transluminal Angioplasty (PTA) will involve the insertion of a catheter into one of the femoral arteries. Once the catheter is in place, a tiny balloon on the end of the catheter will be inflated to press against the narrowing (or blockage) in the artery to try to open the blockage, and allow more blood to flow through the artery. The balloon may need to be inflated several times in order for the narrowed area to open up sufficiently to improve the blood flow. The area will be viewed with specialized x-ray or other imaging devices to see if the artery has opened enough.
The Lutonix® DCB through the blood vessel to the narrowed area to be treated.
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|---|---|
|
Overall Study
Withdrawal by Subject
|
32
|
|
Overall Study
Death
|
170
|
|
Overall Study
Sponsor's decision
|
3
|
|
Overall Study
Investigator's decision
|
44
|
|
Overall Study
Lost to Follow-up
|
81
|
|
Overall Study
Other
|
7
|
|
Overall Study
Ineligible for Major Protocol Deviation
|
39
|
Baseline Characteristics
Real-World Registry Assessing the Clinical Use of the Lutonix 035 Drug Coated Balloon Catheter
Baseline characteristics by cohort
| Measure |
PTA (Lutonix® 035 DCB Catheter)
n=966 Participants
Treatment with the Lutonix 035 DCB will be per the investigational site's standard of care and adhering to the IFU.
PTA (Lutonix® 035 DCB Catheter): Percutaneous Transluminal Angioplasty (PTA) will involve the insertion of a catheter into one of the femoral arteries. Once the catheter is in place, a tiny balloon on the end of the catheter will be inflated to press against the narrowing (or blockage) in the artery to try to open the blockage, and allow more blood to flow through the artery. The balloon may need to be inflated several times in order for the narrowed area to open up sufficiently to improve the blood flow. The area will be viewed with specialized x-ray or other imaging devices to see if the artery has opened enough.
The Lutonix® DCB through the blood vessel to the narrowed area to be treated.
|
|---|---|
|
Age, Customized
Age
|
69.1 Years
STANDARD_DEVIATION 9.79 • n=99 Participants
|
|
Sex: Female, Male
Female
|
418 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
548 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
56 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
910 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
14 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
192 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
735 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
20 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
966 participants
n=99 Participants
|
|
Number of Target Lesions
1 Target Lesion
|
744 Participants
n=99 Participants
|
|
Number of Target Lesions
2 Target Lesions
|
178 Participants
n=99 Participants
|
|
Number of Target Lesions
3 Target Lesions
|
39 Participants
n=99 Participants
|
|
Number of Target Lesions
4 Target Lesions
|
5 Participants
n=99 Participants
|
|
Number of Devices Used
1 device
|
715 Participants
n=99 Participants
|
|
Number of Devices Used
2 devices
|
203 Participants
n=99 Participants
|
|
Number of Devices Used
3 devices
|
43 Participants
n=99 Participants
|
|
Number of Devices Used
4 devices
|
5 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 12 months post-index procedurePopulation: The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.
TLR is defined as the first revascularization procedure (e.g. Percutaneous Transluminal Angioplasty (PTA), stenting, etc.) of the target lesion after the index procedure.
Outcome measures
| Measure |
PTA (Lutonix® 035 DCB Catheter)
n=859 Participants
Treatment with the Lutonix 035 DCB will be per the investigational site's standard of care and adhering to the IFU.
PTA (Lutonix® 035 DCB Catheter): Percutaneous Transluminal Angioplasty (PTA) will involve the insertion of a catheter into one of the femoral arteries. Once the catheter is in place, a tiny balloon on the end of the catheter will be inflated to press against the narrowing (or blockage) in the artery to try to open the blockage, and allow more blood to flow through the artery. The balloon may need to be inflated several times in order for the narrowed area to open up sufficiently to improve the blood flow. The area will be viewed with specialized x-ray or other imaging devices to see if the artery has opened enough.
The Lutonix® DCB through the blood vessel to the narrowed area to be treated.
|
|---|---|
|
Percentage of Participants With Freedom From Target Lesion Revascularization (TLR) at 12 Months Post Index Procedure
|
88.6 percentage of participants
Interval 86.3 to 90.6
|
PRIMARY outcome
Timeframe: 30 days post index procedurePopulation: The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.
Freedom from composite of device and/or procedure related perioperative (≤30 day) death, target limb major amputation (above the ankle), and target vessel revascularization.
Outcome measures
| Measure |
PTA (Lutonix® 035 DCB Catheter)
n=954 Participants
Treatment with the Lutonix 035 DCB will be per the investigational site's standard of care and adhering to the IFU.
PTA (Lutonix® 035 DCB Catheter): Percutaneous Transluminal Angioplasty (PTA) will involve the insertion of a catheter into one of the femoral arteries. Once the catheter is in place, a tiny balloon on the end of the catheter will be inflated to press against the narrowing (or blockage) in the artery to try to open the blockage, and allow more blood to flow through the artery. The balloon may need to be inflated several times in order for the narrowed area to open up sufficiently to improve the blood flow. The area will be viewed with specialized x-ray or other imaging devices to see if the artery has opened enough.
The Lutonix® DCB through the blood vessel to the narrowed area to be treated.
|
|---|---|
|
Percentage of Participants With Freedom From Composite of Device and/or Procedure Related Perioperative Death, Target Limb Major Amputation (Above the Ankle), and Target Vessel Revascularization) at 30 Days Post Index Procedure
|
98.2 Percentage of Participants
Interval 97.2 to 98.9
|
SECONDARY outcome
Timeframe: 6 , 12, 24, and 36 monthsPopulation: The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.
TVR is defined as the first revascularization procedure (e.g. Percutaneous Transluminal Angioplasty (PTA), stenting, surgical bypass, etc.) in the target vessel after the index procedure (Kaplan-Meier estimates).
Outcome measures
| Measure |
PTA (Lutonix® 035 DCB Catheter)
n=966 Participants
Treatment with the Lutonix 035 DCB will be per the investigational site's standard of care and adhering to the IFU.
PTA (Lutonix® 035 DCB Catheter): Percutaneous Transluminal Angioplasty (PTA) will involve the insertion of a catheter into one of the femoral arteries. Once the catheter is in place, a tiny balloon on the end of the catheter will be inflated to press against the narrowing (or blockage) in the artery to try to open the blockage, and allow more blood to flow through the artery. The balloon may need to be inflated several times in order for the narrowed area to open up sufficiently to improve the blood flow. The area will be viewed with specialized x-ray or other imaging devices to see if the artery has opened enough.
The Lutonix® DCB through the blood vessel to the narrowed area to be treated.
|
|---|---|
|
Percentage of Participants With Freedom From Target Vessel Revascularization (TVR) at 6, 12, 24, and 36 Months Post Index Procedure
6 months post index procedure
|
94.7 Percentage of participants
Interval 93.0 to 95.9
|
|
Percentage of Participants With Freedom From Target Vessel Revascularization (TVR) at 6, 12, 24, and 36 Months Post Index Procedure
12 months post index procedure
|
86.5 Percentage of participants
Interval 84.1 to 88.6
|
|
Percentage of Participants With Freedom From Target Vessel Revascularization (TVR) at 6, 12, 24, and 36 Months Post Index Procedure
24 months post index procedure
|
75.7 Percentage of participants
Interval 72.7 to 78.4
|
|
Percentage of Participants With Freedom From Target Vessel Revascularization (TVR) at 6, 12, 24, and 36 Months Post Index Procedure
36 Months Post Index Procedure
|
69.5 Percentage of participants
Interval 66.2 to 72.6
|
SECONDARY outcome
Timeframe: 6, 24, and 36 months post index procedurePopulation: The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.
TLR is defined as the first revascularization procedure (e.g. Percutaneous Transluminal Angioplasty (PTA), stenting, etc.) of the target lesion after the index procedure (Kapln-Meier estimates).
Outcome measures
| Measure |
PTA (Lutonix® 035 DCB Catheter)
n=966 Participants
Treatment with the Lutonix 035 DCB will be per the investigational site's standard of care and adhering to the IFU.
PTA (Lutonix® 035 DCB Catheter): Percutaneous Transluminal Angioplasty (PTA) will involve the insertion of a catheter into one of the femoral arteries. Once the catheter is in place, a tiny balloon on the end of the catheter will be inflated to press against the narrowing (or blockage) in the artery to try to open the blockage, and allow more blood to flow through the artery. The balloon may need to be inflated several times in order for the narrowed area to open up sufficiently to improve the blood flow. The area will be viewed with specialized x-ray or other imaging devices to see if the artery has opened enough.
The Lutonix® DCB through the blood vessel to the narrowed area to be treated.
|
|---|---|
|
Percentage of Participants With Freedom From Target Lesion Revascularization (TLR) at 6, 24, and 36 Months Post Index Procedure.
6 months post index procedure
|
95.9 Percentage of Participants
Interval 94.5 to 97.0
|
|
Percentage of Participants With Freedom From Target Lesion Revascularization (TLR) at 6, 24, and 36 Months Post Index Procedure.
24 months post index procedure
|
79.8 Percentage of Participants
Interval 76.9 to 82.3
|
|
Percentage of Participants With Freedom From Target Lesion Revascularization (TLR) at 6, 24, and 36 Months Post Index Procedure.
36 Months Post Index Procedure
|
74.4 Percentage of Participants
Interval 71.2 to 77.2
|
SECONDARY outcome
Timeframe: At time of Index ProcedurePopulation: The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.
Lesion success defined as attainment of \< 30% residual stenosis of the target lesion after the index procedure using any percutaneous method and/or non-investigational device (i.e., post-dilatation) and no peri-procedural complications (death, stroke, MI, emergent surgical revascularization, significant distal embolization in target limb, and thrombosis of target vessel) prior to hospital discharge.
Outcome measures
| Measure |
PTA (Lutonix® 035 DCB Catheter)
n=966 Participants
Treatment with the Lutonix 035 DCB will be per the investigational site's standard of care and adhering to the IFU.
PTA (Lutonix® 035 DCB Catheter): Percutaneous Transluminal Angioplasty (PTA) will involve the insertion of a catheter into one of the femoral arteries. Once the catheter is in place, a tiny balloon on the end of the catheter will be inflated to press against the narrowing (or blockage) in the artery to try to open the blockage, and allow more blood to flow through the artery. The balloon may need to be inflated several times in order for the narrowed area to open up sufficiently to improve the blood flow. The area will be viewed with specialized x-ray or other imaging devices to see if the artery has opened enough.
The Lutonix® DCB through the blood vessel to the narrowed area to be treated.
|
|---|---|
|
Percentage of Participants With Acute Device and Procedural Success
|
93.0 Percentage of Participants
Interval 91.2 to 94.5
|
SECONDARY outcome
Timeframe: 12 months post-index procedurePopulation: The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.
The absence of target lesion restenosis (defined by Duplex Ultrasound (DUS) peak systolic velocity ratio (PSVR) ≥2.5) and freedom from Target Lesion Revascularization (TLR). Primary Patency at 12-Months post index-procedure by Kaplan-Meier estimates using a Method in which all subjects without a confirmed TLR or loss of patency were censored at Day 395 or the date of study discontinuation, whichever occurred first.
Outcome measures
| Measure |
PTA (Lutonix® 035 DCB Catheter)
n=714 Participants
Treatment with the Lutonix 035 DCB will be per the investigational site's standard of care and adhering to the IFU.
PTA (Lutonix® 035 DCB Catheter): Percutaneous Transluminal Angioplasty (PTA) will involve the insertion of a catheter into one of the femoral arteries. Once the catheter is in place, a tiny balloon on the end of the catheter will be inflated to press against the narrowing (or blockage) in the artery to try to open the blockage, and allow more blood to flow through the artery. The balloon may need to be inflated several times in order for the narrowed area to open up sufficiently to improve the blood flow. The area will be viewed with specialized x-ray or other imaging devices to see if the artery has opened enough.
The Lutonix® DCB through the blood vessel to the narrowed area to be treated.
|
|---|---|
|
Percentage of Participants With Primary Patency at 12 Months Post Index Procedure
|
83.7 Percentage of Participants
Interval 81.1 to 86.0
|
SECONDARY outcome
Timeframe: 6, 12, 24, and 36 Months Post Index ProcedurePopulation: The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.
Freedom from composite of all-cause perioperative (≤30 day) death and from the following: index limb amputation, index limb reintervention, and index-limb-related death (Kaplan-Meier estimates).
Outcome measures
| Measure |
PTA (Lutonix® 035 DCB Catheter)
n=966 Participants
Treatment with the Lutonix 035 DCB will be per the investigational site's standard of care and adhering to the IFU.
PTA (Lutonix® 035 DCB Catheter): Percutaneous Transluminal Angioplasty (PTA) will involve the insertion of a catheter into one of the femoral arteries. Once the catheter is in place, a tiny balloon on the end of the catheter will be inflated to press against the narrowing (or blockage) in the artery to try to open the blockage, and allow more blood to flow through the artery. The balloon may need to be inflated several times in order for the narrowed area to open up sufficiently to improve the blood flow. The area will be viewed with specialized x-ray or other imaging devices to see if the artery has opened enough.
The Lutonix® DCB through the blood vessel to the narrowed area to be treated.
|
|---|---|
|
Percentage of Participants With Freedom From Composite of All-cause Perioperative (≤30 Day) Death and From the Following: Index Limb Amputation, Index Limb Reintervention, and Index-limb-related Death at 6, 12, 24, and 36 Months Post Index Procedure
6 months post index procedure
|
90.3 Percentage of Participants
Interval 88.2 to 92.1
|
|
Percentage of Participants With Freedom From Composite of All-cause Perioperative (≤30 Day) Death and From the Following: Index Limb Amputation, Index Limb Reintervention, and Index-limb-related Death at 6, 12, 24, and 36 Months Post Index Procedure
12 months post index procedure
|
80.8 Percentage of Participants
Interval 78.0 to 83.3
|
|
Percentage of Participants With Freedom From Composite of All-cause Perioperative (≤30 Day) Death and From the Following: Index Limb Amputation, Index Limb Reintervention, and Index-limb-related Death at 6, 12, 24, and 36 Months Post Index Procedure
24 months post index procedure
|
67.4 Percentage of Participants
Interval 64.1 to 70.6
|
|
Percentage of Participants With Freedom From Composite of All-cause Perioperative (≤30 Day) Death and From the Following: Index Limb Amputation, Index Limb Reintervention, and Index-limb-related Death at 6, 12, 24, and 36 Months Post Index Procedure
36 Months Post Index Procedure
|
58.4 Percentage of Participants
Interval 54.8 to 61.9
|
SECONDARY outcome
Timeframe: 6, 12, 24, and 36 Months Post Index ProcedurePopulation: The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.
Freedom from major amputation of the target limb defined as above the ankle amputation
Outcome measures
| Measure |
PTA (Lutonix® 035 DCB Catheter)
n=966 Participants
Treatment with the Lutonix 035 DCB will be per the investigational site's standard of care and adhering to the IFU.
PTA (Lutonix® 035 DCB Catheter): Percutaneous Transluminal Angioplasty (PTA) will involve the insertion of a catheter into one of the femoral arteries. Once the catheter is in place, a tiny balloon on the end of the catheter will be inflated to press against the narrowing (or blockage) in the artery to try to open the blockage, and allow more blood to flow through the artery. The balloon may need to be inflated several times in order for the narrowed area to open up sufficiently to improve the blood flow. The area will be viewed with specialized x-ray or other imaging devices to see if the artery has opened enough.
The Lutonix® DCB through the blood vessel to the narrowed area to be treated.
|
|---|---|
|
Percentage of Participants With Freedom From Major Amputation of the Target Limb (Above the Ankle Amputation) at 6, 12, 24, and 36 Months Post Index Procedure.
6 months post index procedure
|
98.5 Percentage of Participants
Interval 97.4 to 99.2
|
|
Percentage of Participants With Freedom From Major Amputation of the Target Limb (Above the Ankle Amputation) at 6, 12, 24, and 36 Months Post Index Procedure.
12 months post index procedure
|
97.5 Percentage of Participants
Interval 96.3 to 98.5
|
|
Percentage of Participants With Freedom From Major Amputation of the Target Limb (Above the Ankle Amputation) at 6, 12, 24, and 36 Months Post Index Procedure.
24 months post index procedure
|
96.6 Percentage of Participants
Interval 95.1 to 97.8
|
|
Percentage of Participants With Freedom From Major Amputation of the Target Limb (Above the Ankle Amputation) at 6, 12, 24, and 36 Months Post Index Procedure.
36 Months post Index Procedure
|
95.6 Percentage of Participants
Interval 93.8 to 97.0
|
Adverse Events
PTA (Lutonix® 035 DCB Catheter)
Serious events: 65 serious events
Other events: 121 other events
Deaths: 173 deaths
Serious adverse events
| Measure |
PTA (Lutonix® 035 DCB Catheter)
n=1005 participants at risk
Treatment with the Lutonix 035 DCB will be per the investigational site's standard of care and adhering to the IFU.
PTA (Lutonix® 035 DCB Catheter): Percutaneous Transluminal Angioplasty (PTA) will involve the insertion of a catheter into one of the femoral arteries. Once the catheter is in place, a tiny balloon on the end of the catheter will be inflated to press against the narrowing (or blockage) in the artery to try to open the blockage, and allow more blood to flow through the artery. The balloon may need to be inflated several times in order for the narrowed area to open up sufficiently to improve the blood flow. The area will be viewed with specialized x-ray or other imaging devices to see if the artery has opened enough.
The Lutonix® DCB through the blood vessel to the narrowed area to be treated.
|
|---|---|
|
Cardiac disorders
Atrial Fibrillation
|
0.10%
1/1005 • Adverse Events (AEs) are collected from the index procedure through final contact with the participants (36 months post index procedure), or early termination and include events experienced by ALL enrolled participants (1005).
|
|
Cardiac disorders
Myocardial Infarction
|
0.10%
1/1005 • Adverse Events (AEs) are collected from the index procedure through final contact with the participants (36 months post index procedure), or early termination and include events experienced by ALL enrolled participants (1005).
|
|
Gastrointestinal disorders
Retroperitoneal Haemorrhage
|
0.30%
3/1005 • Adverse Events (AEs) are collected from the index procedure through final contact with the participants (36 months post index procedure), or early termination and include events experienced by ALL enrolled participants (1005).
|
|
General disorders
Vessel Puncture Site Haematoma
|
0.40%
4/1005 • Adverse Events (AEs) are collected from the index procedure through final contact with the participants (36 months post index procedure), or early termination and include events experienced by ALL enrolled participants (1005).
|
|
General disorders
Complication of Device removal
|
0.10%
1/1005 • Adverse Events (AEs) are collected from the index procedure through final contact with the participants (36 months post index procedure), or early termination and include events experienced by ALL enrolled participants (1005).
|
|
General disorders
Impaired Healing
|
0.10%
1/1005 • Adverse Events (AEs) are collected from the index procedure through final contact with the participants (36 months post index procedure), or early termination and include events experienced by ALL enrolled participants (1005).
|
|
General disorders
Thrombosis in Device
|
0.10%
1/1005 • Adverse Events (AEs) are collected from the index procedure through final contact with the participants (36 months post index procedure), or early termination and include events experienced by ALL enrolled participants (1005).
|
|
Immune system disorders
Contrast Media Allergy
|
0.10%
1/1005 • Adverse Events (AEs) are collected from the index procedure through final contact with the participants (36 months post index procedure), or early termination and include events experienced by ALL enrolled participants (1005).
|
|
Infections and infestations
Gangrene
|
0.10%
1/1005 • Adverse Events (AEs) are collected from the index procedure through final contact with the participants (36 months post index procedure), or early termination and include events experienced by ALL enrolled participants (1005).
|
|
Infections and infestations
Vessel Puncture Site Infection
|
0.10%
1/1005 • Adverse Events (AEs) are collected from the index procedure through final contact with the participants (36 months post index procedure), or early termination and include events experienced by ALL enrolled participants (1005).
|
|
Injury, poisoning and procedural complications
Vascular Pseudoaneurysm
|
0.80%
8/1005 • Adverse Events (AEs) are collected from the index procedure through final contact with the participants (36 months post index procedure), or early termination and include events experienced by ALL enrolled participants (1005).
|
|
Injury, poisoning and procedural complications
Peripheral Artery Restenosis
|
0.50%
5/1005 • Adverse Events (AEs) are collected from the index procedure through final contact with the participants (36 months post index procedure), or early termination and include events experienced by ALL enrolled participants (1005).
|
|
Injury, poisoning and procedural complications
Procedural Complication
|
0.10%
1/1005 • Adverse Events (AEs) are collected from the index procedure through final contact with the participants (36 months post index procedure), or early termination and include events experienced by ALL enrolled participants (1005).
|
|
Skin and subcutaneous tissue disorders
Skin Ulcer
|
0.10%
1/1005 • Adverse Events (AEs) are collected from the index procedure through final contact with the participants (36 months post index procedure), or early termination and include events experienced by ALL enrolled participants (1005).
|
|
Vascular disorders
Peripheral Artery Dissection
|
2.5%
25/1005 • Adverse Events (AEs) are collected from the index procedure through final contact with the participants (36 months post index procedure), or early termination and include events experienced by ALL enrolled participants (1005).
|
|
Vascular disorders
Peripheral Arterial Occlusive Disease
|
0.70%
7/1005 • Adverse Events (AEs) are collected from the index procedure through final contact with the participants (36 months post index procedure), or early termination and include events experienced by ALL enrolled participants (1005).
|
|
Vascular disorders
Vessel Perforation
|
0.40%
4/1005 • Adverse Events (AEs) are collected from the index procedure through final contact with the participants (36 months post index procedure), or early termination and include events experienced by ALL enrolled participants (1005).
|
|
Vascular disorders
Embolism Arterial
|
0.20%
2/1005 • Adverse Events (AEs) are collected from the index procedure through final contact with the participants (36 months post index procedure), or early termination and include events experienced by ALL enrolled participants (1005).
|
|
Vascular disorders
Peripheral Artery Stenosis
|
0.20%
2/1005 • Adverse Events (AEs) are collected from the index procedure through final contact with the participants (36 months post index procedure), or early termination and include events experienced by ALL enrolled participants (1005).
|
|
Vascular disorders
Peripheral Artery Thrombosis
|
0.10%
1/1005 • Adverse Events (AEs) are collected from the index procedure through final contact with the participants (36 months post index procedure), or early termination and include events experienced by ALL enrolled participants (1005).
|
|
Vascular disorders
Shock
|
0.10%
1/1005 • Adverse Events (AEs) are collected from the index procedure through final contact with the participants (36 months post index procedure), or early termination and include events experienced by ALL enrolled participants (1005).
|
|
Vascular disorders
Vasospasm
|
0.10%
1/1005 • Adverse Events (AEs) are collected from the index procedure through final contact with the participants (36 months post index procedure), or early termination and include events experienced by ALL enrolled participants (1005).
|
Other adverse events
| Measure |
PTA (Lutonix® 035 DCB Catheter)
n=1005 participants at risk
Treatment with the Lutonix 035 DCB will be per the investigational site's standard of care and adhering to the IFU.
PTA (Lutonix® 035 DCB Catheter): Percutaneous Transluminal Angioplasty (PTA) will involve the insertion of a catheter into one of the femoral arteries. Once the catheter is in place, a tiny balloon on the end of the catheter will be inflated to press against the narrowing (or blockage) in the artery to try to open the blockage, and allow more blood to flow through the artery. The balloon may need to be inflated several times in order for the narrowed area to open up sufficiently to improve the blood flow. The area will be viewed with specialized x-ray or other imaging devices to see if the artery has opened enough.
The Lutonix® DCB through the blood vessel to the narrowed area to be treated.
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|---|---|
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Cardiac disorders
Atrial Fibrillation
|
0.10%
1/1005 • Number of events 1 • Adverse Events (AEs) are collected from the index procedure through final contact with the participants (36 months post index procedure), or early termination and include events experienced by ALL enrolled participants (1005).
|
|
Cardiac disorders
Myocardial Infarction
|
0.10%
1/1005 • Number of events 1 • Adverse Events (AEs) are collected from the index procedure through final contact with the participants (36 months post index procedure), or early termination and include events experienced by ALL enrolled participants (1005).
|
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Gastrointestinal disorders
Retroperitoneal Hemorrhage
|
0.30%
3/1005 • Number of events 3 • Adverse Events (AEs) are collected from the index procedure through final contact with the participants (36 months post index procedure), or early termination and include events experienced by ALL enrolled participants (1005).
|
|
General disorders
Vessel Puncture Site Hematoma
|
1.8%
18/1005 • Number of events 18 • Adverse Events (AEs) are collected from the index procedure through final contact with the participants (36 months post index procedure), or early termination and include events experienced by ALL enrolled participants (1005).
|
|
General disorders
Local Swelling
|
0.40%
4/1005 • Number of events 4 • Adverse Events (AEs) are collected from the index procedure through final contact with the participants (36 months post index procedure), or early termination and include events experienced by ALL enrolled participants (1005).
|
|
General disorders
Vessel Puncture Site Hemorrhage
|
0.20%
2/1005 • Number of events 2 • Adverse Events (AEs) are collected from the index procedure through final contact with the participants (36 months post index procedure), or early termination and include events experienced by ALL enrolled participants (1005).
|
|
General disorders
Vessel Puncture Site swelling
|
0.20%
2/1005 • Number of events 2 • Adverse Events (AEs) are collected from the index procedure through final contact with the participants (36 months post index procedure), or early termination and include events experienced by ALL enrolled participants (1005).
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|
General disorders
Complication of Device Removal
|
0.10%
1/1005 • Number of events 1 • Adverse Events (AEs) are collected from the index procedure through final contact with the participants (36 months post index procedure), or early termination and include events experienced by ALL enrolled participants (1005).
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General disorders
Thrombosis in device
|
0.10%
1/1005 • Number of events 1 • Adverse Events (AEs) are collected from the index procedure through final contact with the participants (36 months post index procedure), or early termination and include events experienced by ALL enrolled participants (1005).
|
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General disorders
Vessel Puncture Site Pain
|
0.10%
1/1005 • Number of events 1 • Adverse Events (AEs) are collected from the index procedure through final contact with the participants (36 months post index procedure), or early termination and include events experienced by ALL enrolled participants (1005).
|
|
Immune system disorders
Contrast Media Allergy
|
0.10%
1/1005 • Number of events 1 • Adverse Events (AEs) are collected from the index procedure through final contact with the participants (36 months post index procedure), or early termination and include events experienced by ALL enrolled participants (1005).
|
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Infections and infestations
Gangrene
|
0.10%
1/1005 • Number of events 1 • Adverse Events (AEs) are collected from the index procedure through final contact with the participants (36 months post index procedure), or early termination and include events experienced by ALL enrolled participants (1005).
|
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Infections and infestations
Osteomyelitis
|
0.10%
1/1005 • Number of events 1 • Adverse Events (AEs) are collected from the index procedure through final contact with the participants (36 months post index procedure), or early termination and include events experienced by ALL enrolled participants (1005).
|
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Infections and infestations
Urinary Tract Infection
|
0.10%
1/1005 • Number of events 1 • Adverse Events (AEs) are collected from the index procedure through final contact with the participants (36 months post index procedure), or early termination and include events experienced by ALL enrolled participants (1005).
|
|
Infections and infestations
Vessel Puncture Site Infection
|
0.10%
1/1005 • Number of events 1 • Adverse Events (AEs) are collected from the index procedure through final contact with the participants (36 months post index procedure), or early termination and include events experienced by ALL enrolled participants (1005).
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Injury, poisoning and procedural complications
Peripheral Artery Restenosis
|
1.3%
13/1005 • Number of events 13 • Adverse Events (AEs) are collected from the index procedure through final contact with the participants (36 months post index procedure), or early termination and include events experienced by ALL enrolled participants (1005).
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Injury, poisoning and procedural complications
Vascular Pseudoaneurysm
|
1.00%
10/1005 • Number of events 11 • Adverse Events (AEs) are collected from the index procedure through final contact with the participants (36 months post index procedure), or early termination and include events experienced by ALL enrolled participants (1005).
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Injury, poisoning and procedural complications
Procedural Complication
|
0.30%
3/1005 • Number of events 3 • Adverse Events (AEs) are collected from the index procedure through final contact with the participants (36 months post index procedure), or early termination and include events experienced by ALL enrolled participants (1005).
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Injury, poisoning and procedural complications
Procedural Pain
|
0.30%
3/1005 • Number of events 3 • Adverse Events (AEs) are collected from the index procedure through final contact with the participants (36 months post index procedure), or early termination and include events experienced by ALL enrolled participants (1005).
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Injury, poisoning and procedural complications
Scrotal Haematoma
|
0.10%
1/1005 • Number of events 1 • Adverse Events (AEs) are collected from the index procedure through final contact with the participants (36 months post index procedure), or early termination and include events experienced by ALL enrolled participants (1005).
|
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Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.30%
3/1005 • Number of events 3 • Adverse Events (AEs) are collected from the index procedure through final contact with the participants (36 months post index procedure), or early termination and include events experienced by ALL enrolled participants (1005).
|
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Musculoskeletal and connective tissue disorders
Groin Pain
|
0.10%
1/1005 • Number of events 1 • Adverse Events (AEs) are collected from the index procedure through final contact with the participants (36 months post index procedure), or early termination and include events experienced by ALL enrolled participants (1005).
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Skin and subcutaneous tissue disorders
Rash
|
0.10%
1/1005 • Number of events 1 • Adverse Events (AEs) are collected from the index procedure through final contact with the participants (36 months post index procedure), or early termination and include events experienced by ALL enrolled participants (1005).
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Skin and subcutaneous tissue disorders
Skin Exfoliation
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0.10%
1/1005 • Number of events 1 • Adverse Events (AEs) are collected from the index procedure through final contact with the participants (36 months post index procedure), or early termination and include events experienced by ALL enrolled participants (1005).
|
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Skin and subcutaneous tissue disorders
Skin Ulcer
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0.10%
1/1005 • Number of events 1 • Adverse Events (AEs) are collected from the index procedure through final contact with the participants (36 months post index procedure), or early termination and include events experienced by ALL enrolled participants (1005).
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Vascular disorders
Peripheral Artery Dissection
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3.2%
32/1005 • Number of events 32 • Adverse Events (AEs) are collected from the index procedure through final contact with the participants (36 months post index procedure), or early termination and include events experienced by ALL enrolled participants (1005).
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Vascular disorders
Peripheral Arterial Occlusive Disease
|
0.70%
7/1005 • Number of events 7 • Adverse Events (AEs) are collected from the index procedure through final contact with the participants (36 months post index procedure), or early termination and include events experienced by ALL enrolled participants (1005).
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Vascular disorders
Vessel Perforation
|
0.50%
5/1005 • Number of events 5 • Adverse Events (AEs) are collected from the index procedure through final contact with the participants (36 months post index procedure), or early termination and include events experienced by ALL enrolled participants (1005).
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Vascular disorders
Peripheral Artery Stenosis
|
0.40%
4/1005 • Number of events 4 • Adverse Events (AEs) are collected from the index procedure through final contact with the participants (36 months post index procedure), or early termination and include events experienced by ALL enrolled participants (1005).
|
|
Vascular disorders
Peripheral Artery Thrombosis
|
0.40%
4/1005 • Number of events 4 • Adverse Events (AEs) are collected from the index procedure through final contact with the participants (36 months post index procedure), or early termination and include events experienced by ALL enrolled participants (1005).
|
|
Vascular disorders
Embolism Arterial
|
0.30%
3/1005 • Number of events 3 • Adverse Events (AEs) are collected from the index procedure through final contact with the participants (36 months post index procedure), or early termination and include events experienced by ALL enrolled participants (1005).
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Vascular disorders
Hypotension
|
0.30%
3/1005 • Number of events 3 • Adverse Events (AEs) are collected from the index procedure through final contact with the participants (36 months post index procedure), or early termination and include events experienced by ALL enrolled participants (1005).
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Vascular disorders
Arteriovenous Fistula
|
0.20%
2/1005 • Number of events 2 • Adverse Events (AEs) are collected from the index procedure through final contact with the participants (36 months post index procedure), or early termination and include events experienced by ALL enrolled participants (1005).
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Vascular disorders
Vasospasm
|
0.20%
2/1005 • Number of events 2 • Adverse Events (AEs) are collected from the index procedure through final contact with the participants (36 months post index procedure), or early termination and include events experienced by ALL enrolled participants (1005).
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|
Vascular disorders
Peripheral Artery Aneurysm
|
0.10%
1/1005 • Number of events 1 • Adverse Events (AEs) are collected from the index procedure through final contact with the participants (36 months post index procedure), or early termination and include events experienced by ALL enrolled participants (1005).
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|
Vascular disorders
Shock
|
0.10%
1/1005 • Number of events 1 • Adverse Events (AEs) are collected from the index procedure through final contact with the participants (36 months post index procedure), or early termination and include events experienced by ALL enrolled participants (1005).
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER