Randomized Study of Laser and Balloon Angioplasty Versus Balloon Angioplasty to Treat Peripheral 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.