Randomized Study of Laser and Balloon Angioplasty Versus Balloon Angioplasty to Treat Peripheral In-stent Restenosis (EXCITE ISR)

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
• 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.