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

Not Applicable

Terminated

• Conditions: Restenosis
• Interventions: Device: Spectranetics Laser with adjunct PTA and Gore VIABAHN Endoprosthesis with Heparin Bioactive Surface

• Registration Number: NCT00712257
• Lead Sponsor: VIVA Physicians

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2008-07-03
• Study First Submitted QC: 2008-07-08
• Study First Posted: 2008-07-09
• Primary Completion: 2008-09
• Study Completion: 2009-08
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-02
• Last Update Posted: 2014-06-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 27

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Spectranetics Laser plus Gore Viabahn Endoprosthesis	Spectranetics Laser with adjunct PTA and Gore VIABAHN Endoprosthesis with Heparin Bioactive Surface	Spectranetics Laser for optimal debulking followed by adjunctive PTA plus GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface placement

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Gary Ansel, MD; 🇺🇸 Columbus, Ohio, United States