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

Spectranetics

Status and phase

Completed

Phase 3

Phase 2

Conditions

Peripheral Arterial Disease

Treatments

Procedure: Balloon angioplasty

Device: Turbo Elite Laser and Turbo Tandem Laser Guide Catheters

Study type

Interventional

Funder types

Industry

Identifiers

NCT01330628

D013474

Details and patient eligibility

About

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.

Enrollment

252 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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.