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

Phase 2

Completed

Conditions: Peripheral Arterial Disease

Interventions: Device: Turbo Elite Laser and Turbo Tandem Laser Guide Catheters
Procedure: Balloon angioplasty

Registration Number: NCT01330628

Lead Sponsor: Spectranetics Corporation

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 252

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laser atherectomy and PTA	Turbo Elite Laser and Turbo Tandem Laser Guide Catheters	laser, then balloon angioplasty
Balloon angioplasty	Balloon angioplasty	-

Primary Outcome Measures

Name	Time	Method
Freedom From Target Lesion Revascularization (TLR)	6 months	Number of participants free from Target Lesion Revascularization (TLR) through 6 months follow-up.
Freedom From Major Adverse Events (MAE)	30 days	Number of participants free from Major Adverse Events (MAE) at 30 days. MAE are defined all cause death, major amputation in the target limb, or target lesion revascularization (TLR) from procedure to 30 days (±7 days).

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (34): St. John's - Providence Hospital
🇺🇸
Southfield, Michigan, United States
Thomas Hospital
🇺🇸
Fairhope, Alabama, United States
St. Vincent Heart Clinic Arkansas
🇺🇸
Little Rock, Arkansas, United States
Washington Hospital Center
🇺🇸
Washington, D.C., District of Columbia, United States
Arkansas Heart Hospital
🇺🇸
Little Rock, Arkansas, United States
Memorial Regional Hospital
🇺🇸
Hollywood, Florida, United States
The Cardiac and Vascular Institute
🇺🇸
Gainesville, Florida, United States
Community Hospital
🇺🇸
Munster, Indiana, United States
St. John's Hospital
🇺🇸
Springfield, Illinois, United States
Cardiovascular Consultants
🇺🇸
Bossier, Louisiana, United States
Genesis Health System
🇺🇸
Davenport, Iowa, United States
Regional Medical center of Acadiana
🇺🇸
Lafayette, Louisiana, United States
Opelousas General Hospital
🇺🇸
Opelousas, Louisiana, 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
Wellmont Holston Valley Medical
🇺🇸
Kingsport, Tennessee, United States
Presbyterian Hospital of Dallas
🇺🇸
Dallas, Texas, United States
El Paso Cardiac and Endovascular Center
🇺🇸
El Paso, Texas, United States
Tyler Cardiac and Endovascular Center
🇺🇸
Tyler, Texas, United States
Providence Health Center
🇺🇸
Waco, Texas, United States
Sentara Norfolk General Hospital
🇺🇸
Norfolk, Virginia, United States
Transcatheter Medical Inc.
🇵🇷
San Juan, Puerto Rico
Mount Sinai Medical Center
🇺🇸
Miami, Florida, United States
Steward - St. Elizabeth's
🇺🇸
Boston, Massachusetts, United States
St. Vincent's East
🇺🇸
Birmingham, Alabama, United States
UC-Davis Medical Centers
🇺🇸
Sacramento, California, United States
Yale - New Haven Hospital
🇺🇸
New Haven, Connecticut, United States
St. Luke's Medical Center
🇺🇸
Milwaukee, Wisconsin, United States
Wheaton Franciscan Healthcare - All Saints Hospital
🇺🇸
Milwaukee, Wisconsin, United States