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
- 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.
- 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
- Uncontrolled hypercoagulability