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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)

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ClinicalTrials.gov Identifier: NCT00712257
Recruitment Status : Terminated (Due to safety concerns)
First Posted : July 9, 2008
Last Update Posted : June 4, 2014
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Restenosis Device: Spectranetics Laser with adjunct PTA and Gore VIABAHN Endoprosthesis with Heparin Bioactive Surface

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Intervention Model: Single Group Assignment
Masking: None (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.
Study Start Date : November 2007
Primary Completion Date : September 2008
Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

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 ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: VIVA Physicians
ClinicalTrials.gov Identifier: NCT00712257     History of Changes
Other Study ID Numbers: SALVAGE - 00106-661
First Posted: July 9, 2008    Key Record Dates
Last Update Posted: June 4, 2014
Last Verified: June 2014

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

Additional relevant MeSH terms:
Heparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action