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

Study Overview
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Brief Summary
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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

Official Title
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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.

Conditions
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Restenosis

Intervention / Treatment
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* Device: Spectranetics Laser with adjunct PTA and Gore VIABAHN Endoprosthesis with Heparin Bioactive Surface


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Spectranetics Laser plus Gore Viabahn Endoprosthesis<br>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<br>* treatment for superficial femoral artery instent re-stenosis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 12 month follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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treatment of superficial femoral artery instent restenosis