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

NCT ID: NCT01095237

Last Updated: 2014-07-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2012-11-30

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.

Conditions

Peripheral Arterial Disease; Peripheral Vascular Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

ProEndoTecc Vascular Graft

Implantation of the device as an interponate / bypass of the superficial femoral artery

Intervention Type: DEVICE

Other Intervention Names

ProEndoTecc Vascular Graft Prosthesis

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MDT Medical Device Testing GmbH

INDUSTRY

Sponsor Role: collaborator

NonWoTecc Medical GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Staedtisches Klinikum Karlsruhe gGmbH

Karlsruhe, Baden-Wurttemberg, Germany

Klinikum Deggendorf, Dpt. of Vascular- and Endovascular Surgery

Deggendorf, Bavaria, Germany

Hospital Muenchen-Pasing

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

Evangelisches Krankenhaus Dpt. of Vascular Surgery

Mülheim, North Rhine-Westphalia, Germany

Sana Clinic Remscheid Dpt. of Vascular Surgery

Remscheid, North Rhine-Westphalia, Germany

Countries

Germany

Other Identifiers

mdt-09k006

Identifier Type: -

Identifier Source: org_study_id