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

Peripheral Arterial Disease Clinical Trial

— EXCITE ISR  

Official title:

EXCImer Laser Randomized Controlled Study for Treatment of FemoropopliTEal In-Stent Restenosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01330628
• Other study ID #: D013474
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: April 4, 2011
• Last updated: May 18, 2015
• Start date: June 2011
• Est. completion date: May 2015

Study information

• Verified date: May 2015
• Source: Spectranetics Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 252
• Est. completion date: May 2015
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Device:
• Turbo Elite Laser and Turbo Tandem Laser Guide Catheters
application of laser energy to remove blockage followed by standard balloon angioplasty

Procedure:
• Balloon angioplasty
standard balloon catheters for PTA

Locations

Country	Name	City	State
Puerto Rico	Transcatheter Medical Inc.	San Juan
United States	St. Vincent's East	Birmingham	Alabama
United States	Cardiovascular Consultants	Bossier	Louisiana
United States	Steward - St. Elizabeth's	Boston	Massachusetts
United States	Deborah Heart and Lung	Browns Mills	New Jersey
United States	Bryn Mawr	Bryn Mawr	Pennsylvania
United States	Presbyterian Hospital of Dallas	Dallas	Texas
United States	Genesis Health System	Davenport	Iowa
United States	El Paso Cardiac and Endovascular Center	El Paso	Texas
United States	Thomas Hospital	Fairhope	Alabama
United States	The Cardiac and Vascular Institute	Gainesville	Florida
United States	Hattiesburg Clinic	Hattiesburg	Mississippi
United States	Memorial Regional Hospital	Hollywood	Florida
United States	Wellmont Holston Valley Medical	Kingsport	Tennessee
United States	Regional Medical center of Acadiana	Lafayette	Louisiana
United States	Arkansas Heart Hospital	Little Rock	Arkansas
United States	St. Vincent Heart Clinic Arkansas	Little Rock	Arkansas
United States	Mount Sinai Medical Center	Miami	Florida
United States	St. Luke's Medical Center	Milwaukee	Wisconsin
United States	Wheaton Franciscan Healthcare - All Saints Hospital	Milwaukee	Wisconsin
United States	Community Hospital	Munster	Indiana
United States	Yale - New Haven Hospital	New Haven	Connecticut
United States	New York University	New York	New York
United States	Sentara Norfolk General Hospital	Norfolk	Virginia
United States	Opelousas General Hospital	Opelousas	Louisiana
United States	The Miriam Hospital	Providence	Rhode Island
United States	UC-Davis Medical Centers	Sacramento	California
United States	St. John's - Providence Hospital	Southfield	Michigan
United States	St. John's Hospital	Springfield	Illinois
United States	Tyler Cardiac and Endovascular Center	Tyler	Texas
United States	Providence Health Center	Waco	Texas
United States	Washington Hospital Center	Washington, D.C.	District of Columbia
United States	Coastal Surgery Specialists	Wilmington	North Carolina
United States	Metro Health Hospital	Wyoming	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Spectranetics Corporation

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Target lesion revascularization (TLR)		6 months	No
Primary	Major Adverse Events	death, amputation, target lesion revascularization	30 days	Yes
Secondary	Procedural success	Defined as a =30% stenosis in the target lesion immediately post assigned treatment	(day 1) During the interventional procedure in catheterization laboratory. Procedure may last 1-2 hours.	No
Secondary	Target vessel revascularization		6 and 12 months	No
Secondary	Primary patency	The proportion of subjects, with uninterrupted (intervention-free) patency since the initial procedure. Primary patency ends at the first occurrence of one of the following: reintervention for the purpose of treating the target lesion, total occlusion of the target lesion, surgical bypass of the target, or amputation of the extremity due to target lesion restenosis or occlusion.	1, 6, and 12 months	No
Secondary	Assisted primary patency	Defined as a re-intervention of a stenosis (patent vessel) >50% at the treatment site to prevent reocclusion by angiographic assessment in the target lesion.	1, 6, and 12 months	No
Secondary	Assisted secondary patency	Defined as a re-intervention of a reocclusion (non-patent vessel) at the treatment site by angiographic assessment in the target lesion.	1, 6, and 12 months	No
Secondary	Ankle/Brachial Index (ABI)		1, 6, and 12 months	No
Secondary	Functional status	The Walking Impairment Questionnaire (WIQ) at 30 day follow up will be considered baseline and will be compared to the WIQ at 6 and 12 months.	1, 6, and 12 months	No
Secondary	Rutherford classification		1, 6, and 12 months	No
Secondary	Stent integrity		6 and 12 months	Yes