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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)
W.L.Gore & Associates
Spectranetics Corporation
Information provided by (Responsible Party):
VIVA Physicians Identifier:
First received: July 3, 2008
Last updated: June 2, 2014
Last verified: June 2014
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
Device: Spectranetics Laser with adjunct PTA and Gore VIABAHN Endoprosthesis with Heparin Bioactive Surface

Study Type: Interventional
Study Design: 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 ]

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 ]

Enrollment: 27
Study Start Date: November 2007
Study Completion Date: August 2009
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Spectranetics Laser plus Gore Viabahn Endoprosthesis
Spectranetics Laser for optimal debulking followed by adjunctive PTA plus GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface placement
Device: Spectranetics Laser with adjunct PTA and Gore VIABAHN Endoprosthesis with Heparin Bioactive Surface
treatment for superficial femoral artery instent re-stenosis


Ages Eligible for Study:   18 Years to 89 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00712257

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

Responsible Party: VIVA Physicians Identifier: NCT00712257     History of Changes
Other Study ID Numbers: SALVAGE - 00106-661
Study First Received: July 3, 2008
Last Updated: June 2, 2014

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

Additional relevant MeSH terms:
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action processed this record on May 25, 2017