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

Not Applicable

Terminated

• Conditions: Peripheral Vascular Disease; Peripheral Arterial Disease

• Registration Number: NCT01095237
• Lead Sponsor: NonWoTecc Medical GmbH

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-03-23
• Study First Submitted QC: 2010-03-29
• Study First Posted: 2010-03-30
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-08
• Last Update Posted: 2014-07-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 33

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (12)

Staedtisches Klinikum Karlsruhe gGmbH; 🇩🇪 Karlsruhe, Baden-Wuerttemberg, Germany

Hospital Muenchen-Pasing; 🇩🇪 Muenchen, Bavaria, Germany

Klinikum Deggendorf, Dpt. of Vascular- and Endovascular Surgery; 🇩🇪 Deggendorf, Bavaria, Germany

Klinikum Nuernberg Sued Dpt. of Vascular Surgery; 🇩🇪 Nuernberg, Bavaria, Germany

Krankenhaus Barmherzige Brüder, Dpt. of Vascular Surgery; 🇩🇪 Regensburg, Bavaria, Germany

Klinik fuer Gefaesschirurgie St-Bonifatius-Hospital Lingen; 🇩🇪 Lingen, Lower Saxony, Germany

Knappschaftskrankenhaus Bottrop Dpt. of Vascular Surgery; 🇩🇪 Bottrop, Nordrhein-Westfalen, Germany

Sana Clinic Remscheid Dpt. of Vascular Surgery; 🇩🇪 Remscheid, Nordrhein-Westfalen, Germany

Gefaesschirurgische Klinik St-Marienhospital Bonn; 🇩🇪 Bonn, North Rhine-Westphalia, Germany

Clinic and Polyclinic for Vascular Surgery; 🇩🇪 Cologne, Nordrhein-Westfalen, Germany

Evangelisches Krankenhaus Dpt. of Vascular Surgery; 🇩🇪 Muelheim, Nordrhein-Westfalen, Germany

Luisenhospital Dpt. of Vascular Surgery; 🇩🇪 Aachen, Nordrhein-Westfalen, Germany