Randomized Study of Laser and Balloon Angioplasty Versus Balloon Angioplasty to Treat Peripheral In-stent Restenosis

Study Overview
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Brief Summary
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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.

Official Title
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EXCImer Laser Randomized Controlled Study for Treatment of FemoropopliTEal In-Stent Restenosis

Conditions
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Peripheral Arterial Disease

Intervention / Treatment
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* Device: Turbo Elite Laser and Turbo Tandem Laser Guide Catheters
* Procedure: Balloon angioplasty


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laser atherectomy and PTA<br>laser, then balloon angioplasty | Device: Turbo Elite Laser and Turbo Tandem Laser Guide Catheters<br>* application of laser energy to remove blockage followed by standard balloon angioplasty<br>|
| Active Comparator: Balloon angioplasty<br> | Procedure: Balloon angioplasty<br>* standard balloon catheters for PTA<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom From Target Lesion Revascularization (TLR) | Number of participants free from Target Lesion Revascularization (TLR) through 6 months follow-up. | 6 months | 
| 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). | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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peripheral arterial disease, in stent restenosis, peripheral vascular disease