Trial Outcomes & Findings for Randomized Study of Laser and Balloon Angioplasty Versus Balloon Angioplasty to Treat Peripheral In-stent Restenosis (NCT NCT01330628)
NCT ID: NCT01330628
Last Updated: 2016-08-18
Results Overview
Number of participants free from Target Lesion Revascularization (TLR) through 6 months follow-up.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
252 participants
Primary outcome timeframe
6 months
Results posted on
2016-08-18
Participant Flow
Participant milestones
| Measure |
Laser Atherectomy and PTA
laser, then balloon angioplasty
Turbo Elite Laser and Turbo Tandem Laser Guide Catheters: application of laser energy to remove blockage followed by standard balloon angioplasty
|
Balloon Angioplasty
Balloon angioplasty: standard balloon catheters for PTA
|
|---|---|---|
|
Overall Study
STARTED
|
170
|
82
|
|
Overall Study
30 Day Follow-up
|
165
|
73
|
|
Overall Study
6 Month Follow-up
|
135
|
60
|
|
Overall Study
COMPLETED
|
100
|
42
|
|
Overall Study
NOT COMPLETED
|
70
|
40
|
Reasons for withdrawal
| Measure |
Laser Atherectomy and PTA
laser, then balloon angioplasty
Turbo Elite Laser and Turbo Tandem Laser Guide Catheters: application of laser energy to remove blockage followed by standard balloon angioplasty
|
Balloon Angioplasty
Balloon angioplasty: standard balloon catheters for PTA
|
|---|---|---|
|
Overall Study
Death
|
2
|
3
|
|
Overall Study
Lost to Follow-up
|
5
|
6
|
|
Overall Study
Adverse Event
|
44
|
25
|
|
Overall Study
Withdrawn
|
18
|
6
|
|
Overall Study
Didn't receive study treatment
|
1
|
0
|
Baseline Characteristics
Randomized Study of Laser and Balloon Angioplasty Versus Balloon Angioplasty to Treat Peripheral In-stent Restenosis
Baseline characteristics by cohort
| Measure |
Laser Atherectomy and PTA
n=170 Participants
laser, then balloon angioplasty
Turbo Elite Laser and Turbo Tandem Laser Guide Catheters: application of laser energy to remove blockage followed by standard balloon angioplasty
|
Balloon Angioplasty
n=82 Participants
Balloon angioplasty: standard balloon catheters for PTA
|
Total
n=252 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.6 years
STANDARD_DEVIATION 9.8 • n=99 Participants
|
67.9 years
STANDARD_DEVIATION 10.3 • n=107 Participants
|
68.4 years
STANDARD_DEVIATION 9.9 • n=206 Participants
|
|
Sex: Female, Male
Female
|
64 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
95 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
106 Participants
n=99 Participants
|
51 Participants
n=107 Participants
|
157 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
21 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
149 Participants
n=99 Participants
|
70 Participants
n=107 Participants
|
219 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
22 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
144 Participants
n=99 Participants
|
74 Participants
n=107 Participants
|
218 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
170 participants
n=99 Participants
|
82 participants
n=107 Participants
|
252 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: The number of participants analyzed for this endpoint does not match with the Participant Flow 6 Month Follow-up population. A subject may not complete a 6 Month Follow-up due to missing the visit, being lost to follow-up, etc., but if they had a TLR prior to this time point, they would still be included in this outcome analysis.
Number of participants free from Target Lesion Revascularization (TLR) through 6 months follow-up.
Outcome measures
| Measure |
Laser Atherectomy and PTA
n=157 Participants
laser, then balloon angioplasty
Turbo Elite Laser and Turbo Tandem Laser Guide Catheters: application of laser energy to remove blockage followed by standard balloon angioplasty
|
Balloon Angioplasty
n=73 Participants
Balloon angioplasty: standard balloon catheters for PTA
|
|---|---|---|
|
Freedom From Target Lesion Revascularization (TLR)
|
123 # of participants free from TLR
|
43 # of participants free from TLR
|
PRIMARY outcome
Timeframe: 30 daysPopulation: The number of participants analyzed for this endpoint does not match with the Participant Flow 30 Day Follow-up population. If a subject did not complete a 30 Day Follow-up due to missing the visit or lost to follow-up, but had an MAE prior to this time point, they would still be included in this outcome analysis.
Number of participants free from Major Adverse Events (MAE) at 30 days. MAE are defined all cause death, major amputation in the target limb, or target lesion revascularization (TLR) from procedure to 30 days (±7 days).
Outcome measures
| Measure |
Laser Atherectomy and PTA
n=167 Participants
laser, then balloon angioplasty
Turbo Elite Laser and Turbo Tandem Laser Guide Catheters: application of laser energy to remove blockage followed by standard balloon angioplasty
|
Balloon Angioplasty
n=77 Participants
Balloon angioplasty: standard balloon catheters for PTA
|
|---|---|---|
|
Freedom From Major Adverse Events (MAE)
|
158 # of participants free from MAE
|
61 # of participants free from MAE
|
Adverse Events
Balloon Angioplasty
Serious events: 56 serious events
Other events: 34 other events
Deaths: 0 deaths
Laser Atherectomy and PTA
Serious events: 117 serious events
Other events: 88 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Balloon Angioplasty
n=82 participants at risk
Balloon angioplasty: standard balloon catheters for PTA
|
Laser Atherectomy and PTA
n=170 participants at risk
laser, then balloon angioplasty
Turbo Elite Laser and Turbo Tandem Laser Guide Catheters: application of laser energy to remove blockage followed by standard balloon angioplasty
|
|---|---|---|
|
Infections and infestations
Infection SAEs
|
4.9%
4/82 • Through 1 year
Specific study related terms (death, amputation and/or TLR) are in the Primary Outcomes Table. To summarize the remaining events, they were categorized into general organ class. The general organ classes are inclusive of the specific study related events. All events were adjudicated and categorized by an independent Clinical Events Committee.
|
1.8%
3/170 • Through 1 year
Specific study related terms (death, amputation and/or TLR) are in the Primary Outcomes Table. To summarize the remaining events, they were categorized into general organ class. The general organ classes are inclusive of the specific study related events. All events were adjudicated and categorized by an independent Clinical Events Committee.
|
|
Cardiac disorders
Cardiac SAEs
|
9.8%
8/82 • Through 1 year
Specific study related terms (death, amputation and/or TLR) are in the Primary Outcomes Table. To summarize the remaining events, they were categorized into general organ class. The general organ classes are inclusive of the specific study related events. All events were adjudicated and categorized by an independent Clinical Events Committee.
|
11.2%
19/170 • Through 1 year
Specific study related terms (death, amputation and/or TLR) are in the Primary Outcomes Table. To summarize the remaining events, they were categorized into general organ class. The general organ classes are inclusive of the specific study related events. All events were adjudicated and categorized by an independent Clinical Events Committee.
|
|
General disorders
Other SAEs
|
14.6%
12/82 • Through 1 year
Specific study related terms (death, amputation and/or TLR) are in the Primary Outcomes Table. To summarize the remaining events, they were categorized into general organ class. The general organ classes are inclusive of the specific study related events. All events were adjudicated and categorized by an independent Clinical Events Committee.
|
14.7%
25/170 • Through 1 year
Specific study related terms (death, amputation and/or TLR) are in the Primary Outcomes Table. To summarize the remaining events, they were categorized into general organ class. The general organ classes are inclusive of the specific study related events. All events were adjudicated and categorized by an independent Clinical Events Committee.
|
|
Gastrointestinal disorders
Gastrointestinal SAEs
|
7.3%
6/82 • Through 1 year
Specific study related terms (death, amputation and/or TLR) are in the Primary Outcomes Table. To summarize the remaining events, they were categorized into general organ class. The general organ classes are inclusive of the specific study related events. All events were adjudicated and categorized by an independent Clinical Events Committee.
|
5.3%
9/170 • Through 1 year
Specific study related terms (death, amputation and/or TLR) are in the Primary Outcomes Table. To summarize the remaining events, they were categorized into general organ class. The general organ classes are inclusive of the specific study related events. All events were adjudicated and categorized by an independent Clinical Events Committee.
|
|
Nervous system disorders
Neurological SAEs
|
6.1%
5/82 • Through 1 year
Specific study related terms (death, amputation and/or TLR) are in the Primary Outcomes Table. To summarize the remaining events, they were categorized into general organ class. The general organ classes are inclusive of the specific study related events. All events were adjudicated and categorized by an independent Clinical Events Committee.
|
2.4%
4/170 • Through 1 year
Specific study related terms (death, amputation and/or TLR) are in the Primary Outcomes Table. To summarize the remaining events, they were categorized into general organ class. The general organ classes are inclusive of the specific study related events. All events were adjudicated and categorized by an independent Clinical Events Committee.
|
|
Blood and lymphatic system disorders
Blood related disorder SAEs
|
1.2%
1/82 • Through 1 year
Specific study related terms (death, amputation and/or TLR) are in the Primary Outcomes Table. To summarize the remaining events, they were categorized into general organ class. The general organ classes are inclusive of the specific study related events. All events were adjudicated and categorized by an independent Clinical Events Committee.
|
2.9%
5/170 • Through 1 year
Specific study related terms (death, amputation and/or TLR) are in the Primary Outcomes Table. To summarize the remaining events, they were categorized into general organ class. The general organ classes are inclusive of the specific study related events. All events were adjudicated and categorized by an independent Clinical Events Committee.
|
|
Vascular disorders
Vascular SAEs
|
58.5%
48/82 • Through 1 year
Specific study related terms (death, amputation and/or TLR) are in the Primary Outcomes Table. To summarize the remaining events, they were categorized into general organ class. The general organ classes are inclusive of the specific study related events. All events were adjudicated and categorized by an independent Clinical Events Committee.
|
56.5%
96/170 • Through 1 year
Specific study related terms (death, amputation and/or TLR) are in the Primary Outcomes Table. To summarize the remaining events, they were categorized into general organ class. The general organ classes are inclusive of the specific study related events. All events were adjudicated and categorized by an independent Clinical Events Committee.
|
Other adverse events
| Measure |
Balloon Angioplasty
n=82 participants at risk
Balloon angioplasty: standard balloon catheters for PTA
|
Laser Atherectomy and PTA
n=170 participants at risk
laser, then balloon angioplasty
Turbo Elite Laser and Turbo Tandem Laser Guide Catheters: application of laser energy to remove blockage followed by standard balloon angioplasty
|
|---|---|---|
|
Infections and infestations
Infection
|
4.9%
4/82 • Through 1 year
Specific study related terms (death, amputation and/or TLR) are in the Primary Outcomes Table. To summarize the remaining events, they were categorized into general organ class. The general organ classes are inclusive of the specific study related events. All events were adjudicated and categorized by an independent Clinical Events Committee.
|
5.3%
9/170 • Through 1 year
Specific study related terms (death, amputation and/or TLR) are in the Primary Outcomes Table. To summarize the remaining events, they were categorized into general organ class. The general organ classes are inclusive of the specific study related events. All events were adjudicated and categorized by an independent Clinical Events Committee.
|
|
Cardiac disorders
Cardiac
|
4.9%
4/82 • Through 1 year
Specific study related terms (death, amputation and/or TLR) are in the Primary Outcomes Table. To summarize the remaining events, they were categorized into general organ class. The general organ classes are inclusive of the specific study related events. All events were adjudicated and categorized by an independent Clinical Events Committee.
|
8.8%
15/170 • Through 1 year
Specific study related terms (death, amputation and/or TLR) are in the Primary Outcomes Table. To summarize the remaining events, they were categorized into general organ class. The general organ classes are inclusive of the specific study related events. All events were adjudicated and categorized by an independent Clinical Events Committee.
|
|
General disorders
Other AEs
|
9.8%
8/82 • Through 1 year
Specific study related terms (death, amputation and/or TLR) are in the Primary Outcomes Table. To summarize the remaining events, they were categorized into general organ class. The general organ classes are inclusive of the specific study related events. All events were adjudicated and categorized by an independent Clinical Events Committee.
|
23.5%
40/170 • Through 1 year
Specific study related terms (death, amputation and/or TLR) are in the Primary Outcomes Table. To summarize the remaining events, they were categorized into general organ class. The general organ classes are inclusive of the specific study related events. All events were adjudicated and categorized by an independent Clinical Events Committee.
|
|
Gastrointestinal disorders
Gastrointestinal
|
3.7%
3/82 • Through 1 year
Specific study related terms (death, amputation and/or TLR) are in the Primary Outcomes Table. To summarize the remaining events, they were categorized into general organ class. The general organ classes are inclusive of the specific study related events. All events were adjudicated and categorized by an independent Clinical Events Committee.
|
5.9%
10/170 • Through 1 year
Specific study related terms (death, amputation and/or TLR) are in the Primary Outcomes Table. To summarize the remaining events, they were categorized into general organ class. The general organ classes are inclusive of the specific study related events. All events were adjudicated and categorized by an independent Clinical Events Committee.
|
|
Nervous system disorders
Neurological
|
3.7%
3/82 • Through 1 year
Specific study related terms (death, amputation and/or TLR) are in the Primary Outcomes Table. To summarize the remaining events, they were categorized into general organ class. The general organ classes are inclusive of the specific study related events. All events were adjudicated and categorized by an independent Clinical Events Committee.
|
4.7%
8/170 • Through 1 year
Specific study related terms (death, amputation and/or TLR) are in the Primary Outcomes Table. To summarize the remaining events, they were categorized into general organ class. The general organ classes are inclusive of the specific study related events. All events were adjudicated and categorized by an independent Clinical Events Committee.
|
|
Blood and lymphatic system disorders
Blood related disorders
|
6.1%
5/82 • Through 1 year
Specific study related terms (death, amputation and/or TLR) are in the Primary Outcomes Table. To summarize the remaining events, they were categorized into general organ class. The general organ classes are inclusive of the specific study related events. All events were adjudicated and categorized by an independent Clinical Events Committee.
|
4.1%
7/170 • Through 1 year
Specific study related terms (death, amputation and/or TLR) are in the Primary Outcomes Table. To summarize the remaining events, they were categorized into general organ class. The general organ classes are inclusive of the specific study related events. All events were adjudicated and categorized by an independent Clinical Events Committee.
|
|
Vascular disorders
Vascular
|
29.3%
24/82 • Through 1 year
Specific study related terms (death, amputation and/or TLR) are in the Primary Outcomes Table. To summarize the remaining events, they were categorized into general organ class. The general organ classes are inclusive of the specific study related events. All events were adjudicated and categorized by an independent Clinical Events Committee.
|
31.2%
53/170 • Through 1 year
Specific study related terms (death, amputation and/or TLR) are in the Primary Outcomes Table. To summarize the remaining events, they were categorized into general organ class. The general organ classes are inclusive of the specific study related events. All events were adjudicated and categorized by an independent Clinical Events Committee.
|
Additional Information
Amanda Johnson, VP of Regulatory & Medical Affairs
Spectranetics
Phone: (719) 447-2000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60