Peripheral Arterial Disease
Conditions
Keywords
peripheral arterial disease, in stent restenosis, peripheral vascular disease
Brief summary
The purpose of the study is to evaluate the safety and efficacy of laser atherectomy with balloon angioplasty compared to balloon angioplasty alone in the treatment of above the knee peripheral artery in-stent restenosis.
Interventions
DEVICETurbo Elite Laser and Turbo Tandem Laser Guide Catheters
application of laser energy to remove blockage followed by standard balloon angioplasty
PROCEDUREBalloon angioplasty
standard balloon catheters for PTA
Sponsors
Spectranetics Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* PAD with Rutherford class 1-4 * Resting ABI \<0.9 or abnormal exercise ABI \<0.9 * History of previous femoropopliteal nitinol stenting * Angiographic significant restenosis (\>=50%) * Target lesion length \>=4 cm; no more than 3 cm outside stent at either end * Vessel diameter \>=5 mm and \<=7 mm * At least one widely patent tibial or peroneal artery to the foot
Exclusion criteria
* Patient is pregnant or breast feeding * Evidence of acute limb ischemia * Life expectancy \<12 months * CVA within 60 days of screening * Myocardial infarction within 60 days of procedure * Known allergy to contract media * Known contraindication to aspirin, antiplatelet and anti-coagulation therapies * Uncontrolled hypercoagulability * Present or suspected systemic infection in target limb * Serum creatinine \>= 2.5 mg/dl unless dialysis dependent * Previous treatment to target vessel within 3 months of study procedure * Drug eluting stents or covered stents in target lesion * Ipsilateral and/or contralateral iliac stenosis \>= 50% DS that is not successfully treated prior to index procedure or with final residual stenosis \<= 30% documented by angiography * Planned or predicted cardiovascular surgical or interventional procedures prior to completion of the 30-day follow-up * Identification of any lesion below the target stent in the treated leg \>50% that will require preplanned or predicted treatment within 30 days(prior to the 6 month follow up) * Tibial artery containing a \>50% Diameter Stenosis (DS) by visual estimate after popliteal * Grade 4 or 5 stent fracture affecting target stent or proximal to the target stent, or where evidence of stent protrusion into the lumen is noted on angiography in 2 orthogonal views.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom From Target Lesion Revascularization (TLR) | 6 months | Number of participants free from Target Lesion Revascularization (TLR) through 6 months follow-up. |
| Freedom From Major Adverse Events (MAE) | 30 days | 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). |
Countries
Puerto Rico, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 170 |
| Balloon Angioplasty Balloon angioplasty: standard balloon catheters for PTA | 82 |
| Total | 252 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 44 | 25 |
| Overall Study | Death | 2 | 3 |
| Overall Study | Didn't receive study treatment | 1 | 0 |
| Overall Study | Lost to Follow-up | 5 | 6 |
| Overall Study | Withdrawn | 18 | 6 |
Baseline characteristics
| Characteristic | Laser Atherectomy and PTA | Total | Balloon Angioplasty |
|---|---|---|---|
| Age, Continuous | 68.6 years STANDARD_DEVIATION 9.8 | 68.4 years STANDARD_DEVIATION 9.9 | 67.9 years STANDARD_DEVIATION 10.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 21 Participants | 33 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 149 Participants | 219 Participants | 70 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 22 Participants | 30 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 144 Participants | 218 Participants | 74 Participants |
| Region of Enrollment United States | 170 participants | 252 participants | 82 participants |
| Sex: Female, Male Female | 64 Participants | 95 Participants | 31 Participants |
| Sex: Female, Male Male | 106 Participants | 157 Participants | 51 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 88 / 170 | 34 / 82 |
| serious Total, serious adverse events | 117 / 170 | 56 / 82 |
Outcome results
Primary
Freedom From Major Adverse Events (MAE)
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).
Time frame: 30 days
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Laser Atherectomy and PTA | Freedom From Major Adverse Events (MAE) | 158 # of participants free from MAE |
| Balloon Angioplasty | Freedom From Major Adverse Events (MAE) | 61 # of participants free from MAE |
Primary
Freedom From Target Lesion Revascularization (TLR)
Number of participants free from Target Lesion Revascularization (TLR) through 6 months follow-up.
Time frame: 6 months
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Laser Atherectomy and PTA | Freedom From Target Lesion Revascularization (TLR) | 123 # of participants free from TLR |
| Balloon Angioplasty | Freedom From Target Lesion Revascularization (TLR) | 43 # of participants free from TLR |