TerminatedNot Applicable

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

Stopped: Due to safety concerns

United States27 participantsStarted 2007-11

Plain-language 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

Who can participate

Age range18 Years – 89 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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.

Timeframe: 12 months

Trial details

NCT IDNCT00712257

SponsorVIVA Physicians

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2008-09

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