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

Phase 2

Completed

• Conditions: Peripheral Arterial Disease

• 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

Study Timeline

• Study First Submitted: 2011-04-04
• Study First Submitted QC: 2011-04-06
• Study First Posted: 2011-04-07
• Study Start: 2011-06
• Primary Completion: 2014-03
• Study Completion: 2015-05
• Results First Submitted: 2016-05-04
• Results First Submitted QC: 2016-05-04
• Results First Posted: 2016-06-15
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-19
• Last Update Posted: 2016-08-18

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

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).

Trial Locations

Locations (34)

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

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