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

NonWoTecc Medical

Status

Terminated

Conditions

Peripheral Vascular Disease

Peripheral Arterial Disease

Treatments

Device: ProEndoTecc Vascular Graft

Study type

Interventional

Funder types

Industry

Identifiers

mdt-09k006

Details and patient eligibility

About

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.

Enrollment

33 patients

Sex

All

Ages

18 to 89 years old

Volunteers

No Healthy Volunteers

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