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

Completed · Phase 2/Phase 3

Conditions studied: Peripheral Arterial Disease

In brief

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.

Key facts

Study ID

NCT01330628

Run by

Spectranetics Corporation

People needed

252

Starts

2011-06-01

Expected to finish

2015-05-01

Last updated by the study team

2016-08-18

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• St. Vincent's East — Birmingham, Alabama, United States
• Thomas Hospital — Fairhope, Alabama, United States
• St. Vincent Heart Clinic Arkansas — Little Rock, Arkansas, United States
• Arkansas Heart Hospital — Little Rock, Arkansas, United States
• UC-Davis Medical Centers — Sacramento, California, United States
• Yale - New Haven Hospital — New Haven, Connecticut, United States
• Washington Hospital Center — Washington D.C., District of Columbia, United States
• The Cardiac and Vascular Institute — Gainesville, Florida, United States
• Memorial Regional Hospital — Hollywood, Florida, United States
• Mount Sinai Medical Center — Miami, Florida, United States
• St. John's Hospital — Springfield, Illinois, United States
• Community Hospital — Munster, Indiana, United States
• Genesis Health System — Davenport, Iowa, United States
• Cardiovascular Consultants — Bossier City, Louisiana, United States
• Regional Medical center of Acadiana — Lafayette, Louisiana, United States
• Opelousas General Hospital — Opelousas, Louisiana, United States
• Steward - St. Elizabeth's — Boston, Massachusetts, United States
• St. John's - Providence Hospital — Southfield, Michigan, United States
• Metro Health Hospital — Wyoming, Michigan, United States
• Hattiesburg Clinic — Hattiesburg, Mississippi, United States
• Deborah Heart and Lung — Browns Mills, New Jersey, United States
• New York University — New York, New York, United States
• Coastal Surgery Specialists — Wilmington, North Carolina, United States
• Bryn Mawr — Bryn Mawr, Pennsylvania, United States
• The Miriam Hospital — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

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