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

VIVA Physicians27 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Restenosis

Interventions

Spectranetics Laser with adjunct PTA and Gore VIABAHN Endoprosthesis with Heparin Bioactive SurfaceDEVICE

treatment for superficial femoral artery instent re-stenosis

Eligibility

Sex: ALLMin age: 18 YearsMax age: 89 Years

Medical Language ↔ Plain English

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

Locations (1)

Gary Ansel, MD

Columbus, Ohio, United States

Outcomes

Primary Outcomes

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 Outcomes

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

Data from ClinicalTrials.gov

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