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

VIVA Physicians

Status

Terminated

Conditions

Restenosis

Treatments

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

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00712257

SALVAGE - 00106-661

Details and patient eligibility

About

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

Enrollment

27 patients

Sex

All

Ages

18 to 89 years old

Volunteers

No Healthy Volunteers

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