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

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

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.

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.