Clinical Pilot-Study of ProEndoTecc Vascular Grafts as Superficial Femoral Artery Bypass / Interponate

Multicenter, Clinical Pilot-Study of ProEndoTecc Vascular Grafts (6, 7 or 8 mm Diameter) as Superficial Femoral Artery Bypass/Interponate

This is a multi-center, clinical pilot-study of ProEndoTecc Vascular Grafts (6, 7 or 8 mm Diameter) as superficial femoral artery bypass/interponate.

The aim of this study is to demonstrate safety of implantation, patency and durability of a new type of vascular graft.

Inclusion Criteria:

• Female or male patient from 18 to 89 years of age
• Superficial femoral artery occlusion from 5 to 40 cm in length (above the knee joint),
• Patient must present with intermittent claudication, with resistance to medical therapy and exercise or critical ischemia,
• Patient has Rutherford grade 3, 4, or 5 occlusive vascular disease,
• Women of childbearing age must have negative pregnancy test prior to inclusion

Exclusion Criteria:

• Bleeding diathesis
• Patient has known coagulation disorders including hypercoagulability
• Presence of one or several previously placed endo-prosthesis or grafts in the diseased extremity (below iliacs)
• Other than 6-8 mm diameter graft is needed.
• Patients PAD state is in Fontaine Grade IV, Rutherford Grade 6 (Patient has active infection or pronounced necrosis in the region of graft placement)
• Patient has an acute embolic arterial occlusion
• Life-expectancy less than 6 month due to co-morbidity or other situation that would make the patient an unlikely candidate for follow-up visits
• Patient had percutaneous transluminal angioplasty at the implant site within the previous 30 days
• Participation in another clinical study less than 30 days prior to inclusion
• Patient is in need of, or is scheduled for, a cardiac surgical procedure or a different vascular surgical procedure
• Pregnant or breast feeding female patients
• Multiple graft (implant) needed
• Patients unable to understand the full meaning of the informed consent
• Subjects who, in the opinion of the investigator, will be inappropriate for inclusion into this trial or will not comply with requirements of the study
• Subjects who are imprisoned (according to MPG §20.3)
• Patients who are lawfully kept in an institution
• Participation in this trial at an earlier stage
• Current participation in another clinical trial