Study to Evaluate the Safety and Performance of Spectranetics Laser w/Adjunct PTA and Gore Viabahn Endoprosthesis for Treatment of SFA Instent Restenosis (SALVAGE)

This study has been terminated.
(Due to safety concerns)
Sponsor:
Collaborators:
W.L.Gore & Associates
Spectranetics Corporation
Information provided by:
VIVA Physicians
ClinicalTrials.gov Identifier:
NCT00712257
First received: July 3, 2008
Last updated: February 16, 2010
Last verified: February 2010
  Purpose

A Multicenter study to evaluation the safety and performance of Spectranetics Laser with Adjunct PTA and Gore Viabahn Endoprosthesis for the Treatment of SFA Instent Restenosis


Condition Intervention
Restenosis
Device: Spectranetics Laser with adjunct PTA and Gore VIABAHN Endoprosthesis with Heparin Bioactive Surface

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Multicenter Trial to Evaluate the Safety and Performance of Spectranetics Laser With Adjunct PTA and GORE VIABAHN Endoprosthesis for the Treatment of SFA Instent Restenosis.

Resource links provided by NLM:


Further study details as provided by VIVA Physicians:

Primary Outcome Measures:
  • 12-month duplex-ultrasound defined target lesion patency will be assessed in the enrollment arm. Patency is defined as a ratio of less than 2.0, measured as the upstream peak systolic velocity compared with PSV in the area of greatest stenosis. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Target lesion revascularization will be evaluated at 12 mos. and defined as any pecutaneous or surgical intervention to treat a stenosis or cocclusion of the arget lesion treated at the index procedure. [ Time Frame: 12 month follow up ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: November 2007
Estimated Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Spectranetics Laser with adjunct PTA and Gore VIABAHN Endoprosthesis with Heparin Bioactive Surface
    treatment for superficial femoral artery instent re-stenosis
  Eligibility

Ages Eligible for Study:   18 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject or subject's legal representative informed of the study nature.
  • Subject understands the duration of the study and its follow up visit requirements.
  • Intermittent claudication extending through critical limb ischemia meeting a Rutherford 2-5 category.
  • Subject able to walk unassisted.
  • Female subjects of childbearing potential must have a negative serum pregnancy test 7 days prior to treatment.

Exclusion Criteria:

  • Life expectancy less than 12 months
  • Myocardial infarction less than 3 months prior to procedure
  • Known allergies or sensitivities to heparin, aspirin, other anti-coagulant/antiplatelet therapies and nitinol.
  • Known allergy to contrast media that cannot adequately be pre-medicated prior to study procedure.
  • Uncontrolled hypercoagulability
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00712257

Locations
United States, Ohio
Gary Ansel, MD
Columbus, Ohio, United States, 43214
Sponsors and Collaborators
VIVA Physicians
W.L.Gore & Associates
Spectranetics Corporation
Investigators
Principal Investigator: Tony Das, MD Presbyterian Heart Institute
  More Information

No publications provided

Responsible Party: VIVA Physicians - Dr. John Laird, Jr. - PI, VIVA Physicians
ClinicalTrials.gov Identifier: NCT00712257     History of Changes
Other Study ID Numbers: SALVAGE - 00106-661
Study First Received: July 3, 2008
Last Updated: February 16, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by VIVA Physicians:
treatment of superficial femoral artery instent restenosis

ClinicalTrials.gov processed this record on April 15, 2014