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 (Responsible Party):
VIVA Physicians
ClinicalTrials.gov Identifier:
NCT00712257
First received: July 3, 2008
Last updated: June 2, 2014
Last verified: June 2014
  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 ]

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

  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
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: 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
ClinicalTrials.gov Identifier: NCT00712257     History of Changes
Other Study ID Numbers: SALVAGE - 00106-661
Study First Received: July 3, 2008
Last Updated: June 2, 2014
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Heparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on July 26, 2014