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

July 19, 2016 updated by: Spectranetics Corporation

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

252

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Freedom From Target Lesion Revascularization (TLR)
Time Frame: 6 months
Number of participants free from Target Lesion Revascularization (TLR) through 6 months follow-up.
6 months
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).
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Spectranetics Corporation

Investigators

  • Principal Investigator: Eric J Dippel, MD, Genesis Health System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (ACTUAL)

March 1, 2014

Study Completion (ACTUAL)

May 1, 2015

Study Registration Dates

First Submitted

April 4, 2011

First Submitted That Met QC Criteria

April 6, 2011

First Posted (ESTIMATE)

April 7, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

August 18, 2016

Last Update Submitted That Met QC Criteria

July 19, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D013474

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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