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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
33
Implantation of the device as an interponate / bypass of the superficial femoral artery
Staedtisches Klinikum Karlsruhe gGmbH
Karlsruhe, Baden-Wurttemberg, Germany
Klinikum Deggendorf, Dpt. of Vascular- and Endovascular Surgery
Deggendorf, Bavaria, Germany
Hospital Muenchen-Pasing
Primary patency of device
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.
Time frame: 6, 12, 24 months after implatation
Guarding Safety variables
* Peri-interventional monitoring resp. haemorrhages, haematomas * Aneurysm in the grafted segment * Fistula to the grafted segment * Fibrosis at and around implantation site * Death
Time frame: 6,12, 24 months after implantation
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Munich, Bavaria, Germany
Klinikum Nuernberg Sued Dpt. of Vascular Surgery
Nuremberg, Bavaria, Germany
Krankenhaus Barmherzige Brüder, Dpt. of Vascular Surgery
Regensburg, Bavaria, Germany
Klinik fuer Gefaesschirurgie St-Bonifatius-Hospital Lingen
Lingen, Lower Saxony, Germany
Luisenhospital Dpt. of Vascular Surgery
Aachen, North Rhine-Westphalia, Germany
Gefaesschirurgische Klinik St-Marienhospital Bonn
Bonn, North Rhine-Westphalia, Germany
Knappschaftskrankenhaus Bottrop Dpt. of Vascular Surgery
Bottrop, North Rhine-Westphalia, Germany
Clinic and Polyclinic for Vascular Surgery
Cologne, North Rhine-Westphalia, Germany
...and 2 more locations