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

Stopped early · Not applicable

Conditions studied: Restenosis

In brief

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

Key facts

Study ID

NCT00712257

Run by

VIVA Physicians

People needed

27

Starts

2007-11-01

Expected to finish

2009-08-01

Last updated by the study team

2014-06-04

Who can join

Age: 18 and older, up to 89. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Gary Ansel, MD — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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