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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Spectranetics Corporation
Sponsor:
Information provided by (Responsible Party):
Spectranetics Corporation
ClinicalTrials.gov Identifier:
NCT01330628
First received: April 4, 2011
Last updated: September 23, 2013
Last verified: September 2013
  Purpose

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 Intervention Phase
Peripheral Arterial Disease
Device: Turbo Elite Laser and Turbo Tandem Laser Guide Catheters
Procedure: Balloon angioplasty
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: EXCImer Laser Randomized Controlled Study for Treatment of FemoropopliTEal In-Stent Restenosis

Resource links provided by NLM:


Further study details as provided by Spectranetics Corporation:

Primary Outcome Measures:
  • Target lesion revascularization (TLR) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Major Adverse Events [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    death, amputation, target lesion revascularization


Secondary Outcome Measures:
  • Procedural success [ Time Frame: (day 1) During the interventional procedure in catheterization laboratory. Procedure may last 1-2 hours. ] [ Designated as safety issue: No ]
    Defined as a ≤30% stenosis in the target lesion immediately post assigned treatment

  • Target vessel revascularization [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • Primary patency [ Time Frame: 1, 6, and 12 months ] [ Designated as safety issue: No ]
    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.

  • Assisted primary patency [ Time Frame: 1, 6, and 12 months ] [ Designated as safety issue: No ]
    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.

  • Assisted secondary patency [ Time Frame: 1, 6, and 12 months ] [ Designated as safety issue: No ]
    Defined as a re-intervention of a reocclusion (non-patent vessel) at the treatment site by angiographic assessment in the target lesion.

  • Ankle/Brachial Index (ABI) [ Time Frame: 1, 6, and 12 months ] [ Designated as safety issue: No ]
  • Functional status [ Time Frame: 1, 6, and 12 months ] [ Designated as safety issue: No ]
    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.

  • Rutherford classification [ Time Frame: 1, 6, and 12 months ] [ Designated as safety issue: No ]
  • Stent integrity [ Time Frame: 6 and 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 353
Study Start Date: June 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01330628

Contacts
Contact: Chris DeMorett 719-447-2211 christopher.demorett@spnc.com
Contact: Matthew Stark, PhD 719-447-2409 matthew.stark@spnc.com

  Hide Study Locations
Locations
United States, Alabama
St. Vincent's East Recruiting
Birmingham, Alabama, United States, 35235
Contact: Shelley Hall, RN    205-815-4779    shall@birminghamheart.com   
Principal Investigator: Robert Foster, M.D.         
Thomas Hospital Recruiting
Fairhope, Alabama, United States, 36533
Contact: Mary Austin    251-990-1936    maustin@cardassoc.com   
Principal Investigator: Frank Bunch, M.D.         
United States, Arkansas
Arkansas Heart Hospital Recruiting
Little Rock, Arkansas, United States, 72211
Contact: Teresa Dunegan, RN, CRC    501-748-8408    tdunegan@arheart.com   
Principal Investigator: Jeffrey Stewart, M.D.         
St. Vincent Heart Clinic Arkansas Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Jesse Byrd    501-255-6138    jbyrd@heartclinicarkansas.com   
Principal Investigator: John Colleran         
United States, California
UC-Davis Medical Centers Recruiting
Sacramento, California, United States, 95817
Contact: Kimberley Book, RN, BS, CCRP    916-734-5639    kimberley.book@ucdmc.ucdavis.edu   
Principal Investigator: John Laird, M.D.         
United States, Connecticut
Yale - New Haven Hospital Recruiting
New Haven, Connecticut, United States, 06510
Contact: Jackie Gamberdella    203-737-1899    jacqueline.gamberdella@yale.edu   
Principal Investigator: Carlos Mena-Hurtado         
United States, District of Columbia
Washington Hospital Center Recruiting
Washington, D.C., District of Columbia, United States, 20010
Contact: Suman Singh, MD    202-877-8475      
Principal Investigator: Nelson Bernardo, MD         
United States, Florida
The Cardiac and Vascular Institute Recruiting
Gainesville, Florida, United States, 32605
Contact: Sandra Knight    352-244-0208    sknight@tcavi.com   
Principal Investigator: Arthur Lee         
Memorial Regional Hospital Recruiting
Hollywood, Florida, United States, 33021
Contact: Daisy Corchado    954-237-6286    dcorchado@rpna.net   
Principal Investigator: Juan Pastor         
Mount Sinai Medical Center Recruiting
Miami, Florida, United States, 33140
Contact: Nancy Cabrera    305-674-2121    ncabrera@msmc.com   
Principal Investigator: Robert Beasley, M.D.         
United States, Illinois
St. John's Hospital Recruiting
Springfield, Illinois, United States, 62874
Contact: Sadie Samson, RN, BSN    217-492-9100 ext 115    ssamson@prairieresearch.com   
Principal Investigator: Jeffrey Goldstein, M.D.         
United States, Indiana
Community Hospital Recruiting
Munster, Indiana, United States, 46321
Contact: Marsha Garvey    219-934-4200 ext 251    mgarvey@canwi.com   
Principal Investigator: Prakash Makam, M.D.         
United States, Iowa
Genesis Health System Recruiting
Davenport, Iowa, United States, 52803
Contact: Desyree Weakley    563-324-2992    weakleyd@genesishealth.com   
Principal Investigator: Eric Dippel, M.D.         
United States, Louisiana
Cardiovascular Consultants Recruiting
Bossier, Louisiana, United States, 71111
Contact: Stacey Wright    318-548-9908    swcrozier@yahoo.com   
Principal Investigator: Britton Eaves         
Regional Medical center of Acadiana Recruiting
Lafayette, Louisiana, United States, 70506
Contact: Cindy Landry    337-291-6961    cindy.landry@cardio.com   
Principal Investigator: Raghotham Patlola, M.D.         
Opelousas General Hospital Recruiting
Opelousas, Louisiana, United States, 70570
Contact: Nancy Domingue    337-407-3203    nancy.domingue@cardio.com   
Principal Investigator: Kalyan Veerina         
United States, Massachusetts
Steward - St. Elizabeth's Recruiting
Boston, Massachusetts, United States, 02135
Contact: Mary Perianayagam    617-779-6633    mary.perianayagam@steward.org   
Principal Investigator: Lawrence Garcia         
United States, Michigan
St. John's - Providence Hospital Recruiting
Southfield, Michigan, United States, 48075
Contact: Jean Kelly    248-849-3369    jean.kelly@providence-stjohnhealth.org   
Principal Investigator: Marcel Zughaib         
Metro Health Hospital Recruiting
Wyoming, Michigan, United States, 49519
Contact: Carolyn Fox    616-252-5104    carolyn.fox@metrogr.org   
Principal Investigator: Jihad Mustapha         
United States, Mississippi
Hattiesburg Clinic Recruiting
Hattiesburg, Mississippi, United States, 39401
Contact: Frances Findley    601-268-5794    frances.findley@hattiesburgclinic.com   
Principal Investigator: Robert Wilkins         
United States, New Jersey
Deborah Heart and Lung Recruiting
Browns Mills, New Jersey, United States, 08015
Contact: Linda Dewey, CCRC    609-893-6611 ext 5023    deweyl@deborah.org   
Principal Investigator: Richard Kovach, M.D.         
United States, New York
New York University Recruiting
New York, New York, United States, 10016
Contact: Susanna Zavlunova    212-263-5656    susanna.zavlunova@nyumc.org   
Principal Investigator: Anvar Babaev, M.D.         
United States, North Carolina
Coastal Surgery Specialists Recruiting
Wilmington, North Carolina, United States, 284001
Contact: Tracy Smith    910-343-0296 ext 116    tsmith@coastalsurgery.com   
Principal Investigator: David Weatherford         
United States, Pennsylvania
Bryn Mawr Recruiting
Bryn Mawr, Pennsylvania, United States, 19010
Contact: Lynn Sher, CRC    484-476-8581    sherl@mlhs.org   
Principal Investigator: Antonis Pratsos         
United States, Rhode Island
The Miriam Hospital Recruiting
Providence, Rhode Island, United States, 02904
Contact: Lori DeSimone, RN    401-793-5554    ldesimone@lifespan.org   
Principal Investigator: Peter Soukas, M.D.         
United States, Tennessee
Wellmont Holston Valley Medical Recruiting
Kingsport, Tennessee, United States, 37660
Contact: Brandy Venable, RN, CRC    423-230-5618    bvenable@mycva.com   
Principal Investigator: Christopher Metzger, M.D.         
United States, Texas
Presbyterian Hospital of Dallas Recruiting
Dallas, Texas, United States, 75230
Contact: Angelia Hannah, LVN    469-916-7809    ahannah@civadallas.com   
Principal Investigator: Tony Das, M.D.         
El Paso Cardiac and Endovascular Center Recruiting
El Paso, Texas, United States, 79902
Contact: Mario Vela    915-532-6767    mcvelantino@gmail.com   
Principal Investigator: Laiq Raja         
Tyler Cardiac and Endovascular Center Recruiting
Tyler, Texas, United States, 75701
Contact: Pam Dicamillo    903-592-4100    pam@tadresearch.com   
Principal Investigator: Jeff Carr         
Providence Health Center Recruiting
Waco, Texas, United States, 76712
Contact: Samina Ali    254-751-4143    sali@phn-waco.org   
Principal Investigator: Wayne Falcone         
United States, Virginia
Sentara Norfolk General Hospital Recruiting
Norfolk, Virginia, United States, 23507
Contact: Jan Devlin, RN    757-622-2649    JLdevlin@sentara.com   
Principal Investigator: Jean Panneton, M.D.         
United States, Wisconsin
Wheaton Franciscan Healthcare - All Saints Hospital Recruiting
Milwaukee, Wisconsin, United States, 53212
Contact: Tim Babin, BS, CCRC    262-687-8138    timothy.babin@wfhc.org   
Principal Investigator: Thomas Shimshak         
St. Luke's Medical Center Recruiting
Milwaukee, Wisconsin, United States, 53215
Contact: Donald Lobacz, RN. CCRC    414-649-3438    donald.lobacz@aurora.org   
Principal Investigator: Anjan Gupta, M.D.         
Puerto Rico
Transcatheter Medical Inc. Recruiting
San Juan, Puerto Rico, 00926
Contact: Mildred Vega    787-771-3030    transcathetermedical@yahoo.com   
Principal Investigator: Pedro Colon-Hernandez         
Sponsors and Collaborators
Spectranetics Corporation
Investigators
Principal Investigator: Eric J Dippel, MD Genesis Health System
  More Information

No publications provided

Responsible Party: Spectranetics Corporation
ClinicalTrials.gov Identifier: NCT01330628     History of Changes
Other Study ID Numbers: D013474
Study First Received: April 4, 2011
Last Updated: September 23, 2013
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on September 18, 2014