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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01330628
Recruitment Status : Completed
First Posted : April 7, 2011
Results First Posted : June 15, 2016
Last Update Posted : August 18, 2016
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Device: Turbo Elite Laser and Turbo Tandem Laser Guide Catheters Procedure: Balloon angioplasty Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 252 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: EXCImer Laser Randomized Controlled Study for Treatment of FemoropopliTEal In-Stent Restenosis
Study Start Date : June 2011
Actual Primary Completion Date : March 2014
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Laser atherectomy and PTA
laser, then balloon angioplasty
Device: Turbo Elite Laser and Turbo Tandem Laser Guide Catheters
application of laser energy to remove blockage followed by standard balloon angioplasty

Active Comparator: Balloon angioplasty Procedure: Balloon angioplasty
standard balloon catheters for PTA

Primary Outcome Measures :
  1. Freedom From Target Lesion Revascularization (TLR) [ Time Frame: 6 months ]
    Number of participants free from Target Lesion Revascularization (TLR) through 6 months follow-up.

  2. Freedom From Major Adverse Events (MAE) [ Time Frame: 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).

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01330628

  Hide Study Locations
United States, Alabama
St. Vincent's East
Birmingham, Alabama, United States, 35235
Thomas Hospital
Fairhope, Alabama, United States, 36533
United States, Arkansas
St. Vincent Heart Clinic Arkansas
Little Rock, Arkansas, United States, 72205
Arkansas Heart Hospital
Little Rock, Arkansas, United States, 72211
United States, California
UC-Davis Medical Centers
Sacramento, California, United States, 95817
United States, Connecticut
Yale - New Haven Hospital
New Haven, Connecticut, United States, 06510
United States, District of Columbia
Washington Hospital Center
Washington, D.C., District of Columbia, United States, 20010
United States, Florida
The Cardiac and Vascular Institute
Gainesville, Florida, United States, 32605
Memorial Regional Hospital
Hollywood, Florida, United States, 33021
Mount Sinai Medical Center
Miami, Florida, United States, 33140
United States, Illinois
St. John's Hospital
Springfield, Illinois, United States, 62874
United States, Indiana
Community Hospital
Munster, Indiana, United States, 46321
United States, Iowa
Genesis Health System
Davenport, Iowa, United States, 52803
United States, Louisiana
Cardiovascular Consultants
Bossier, Louisiana, United States, 71111
Regional Medical center of Acadiana
Lafayette, Louisiana, United States, 70506
Opelousas General Hospital
Opelousas, Louisiana, United States, 70570
United States, Massachusetts
Steward - St. Elizabeth's
Boston, Massachusetts, United States, 02135
United States, Michigan
St. John's - Providence Hospital
Southfield, Michigan, United States, 48075
Metro Health Hospital
Wyoming, Michigan, United States, 49519
United States, Mississippi
Hattiesburg Clinic
Hattiesburg, Mississippi, United States, 39401
United States, New Jersey
Deborah Heart and Lung
Browns Mills, New Jersey, United States, 08015
United States, New York
New York University
New York, New York, United States, 10016
United States, North Carolina
Coastal Surgery Specialists
Wilmington, North Carolina, United States, 284001
United States, Pennsylvania
Bryn Mawr
Bryn Mawr, Pennsylvania, United States, 19010
United States, Rhode Island
The Miriam Hospital
Providence, Rhode Island, United States, 02904
United States, Tennessee
Wellmont Holston Valley Medical
Kingsport, Tennessee, United States, 37660
United States, Texas
Presbyterian Hospital of Dallas
Dallas, Texas, United States, 75230
El Paso Cardiac and Endovascular Center
El Paso, Texas, United States, 79902
Tyler Cardiac and Endovascular Center
Tyler, Texas, United States, 75701
Providence Health Center
Waco, Texas, United States, 76712
United States, Virginia
Sentara Norfolk General Hospital
Norfolk, Virginia, United States, 23507
United States, Wisconsin
Wheaton Franciscan Healthcare - All Saints Hospital
Milwaukee, Wisconsin, United States, 53212
St. Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215
Puerto Rico
Transcatheter Medical Inc.
San Juan, Puerto Rico, 00926
Sponsors and Collaborators
Spectranetics Corporation
Principal Investigator: Eric J Dippel, MD Genesis Health System

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Spectranetics Corporation Identifier: NCT01330628     History of Changes
Other Study ID Numbers: D013474
First Posted: April 7, 2011    Key Record Dates
Results First Posted: June 15, 2016
Last Update Posted: August 18, 2016
Last Verified: July 2016

Keywords provided by Spectranetics Corporation:
peripheral arterial disease
in stent restenosis
peripheral vascular disease

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases