Peripheral Arterial Disease, Peripheral Vascular Disease
Conditions
Keywords
Peripheral Arterial Disease, Peripheral Vascular Disease, PAD, vascular prosthesis, revascularization, patency, blood vessel, Rutherford, ABI, Ankle Brachial Index, Vascular Graft, Carbothane, ProEndoTecc, implantation
Brief summary
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.
Interventions
DEVICEProEndoTecc Vascular Graft
Implantation of the device as an interponate / bypass of the superficial femoral artery
Sponsors
MDT Medical Device Testing GmbH
NonWoTecc Medical GmbH
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary patency of device | 6, 12, 24 months after implatation | Primary Patency of treated arterial segment at 6 month after intervention. Primary Patency is defined by objective demonstration via colour-coded Doppler sonography or angiography that the entire length of the graft remain patent with no further intervention required for symptomatic recurrent disease. In case this information is not available, primary patency might be declared, if any the following criteria are fulfilled: Present ABI increased of ≥0.1 compared to preoperative status Present PAD-Grade according to Rutherford increased by one degree Palpable pulse distal of prosthesis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Guarding Safety variables | 6,12, 24 months after implantation | * Peri-interventional monitoring resp. haemorrhages, haematomas * Aneurysm in the grafted segment * Fistula to the grafted segment * Fibrosis at and around implantation site * Death |
Countries
Germany
Outcome results
None listed