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

NCT01095237 | Terminated DMC

• 1 other identifier: mdt-09k006
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 12

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

Keywords

Peripheral Arterial Disease; Peripheral Vascular Disease; PAD; vascular prosthesis; revascularization; patency; blood vessel; Rutherford; ABI; Ankle Brachial Index; Vascular Graft; Carbothane; ProEndoTecc; implantation

Outcome Measures

Primary Outcomes (1)

• 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.

  6, 12, 24 months after implatation

Secondary Outcomes (1)

• Guarding Safety variables

  6,12, 24 months after implantation

Interventions

ProEndoTecc Vascular Graft DEVICE

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

Also known as: ProEndoTecc Vascular Graft Prosthesis

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

• 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
• 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 are imprisoned (according to MPG §20.3)
• Patients who are lawfully kept in an institution
• Participation in this trial at an earlier stage

Sponsors & Collaborators

• NonWoTecc Medical GmbH: lead
• MDT Medical Device Testing GmbH: collaborator

Study Sites (12)

Staedtisches Klinikum Karlsruhe gGmbH

Karlsruhe, Baden-Wurttemberg, 76133, Germany

Location

Klinikum Deggendorf, Dpt. of Vascular- and Endovascular Surgery

Deggendorf, Bavaria, 94469, Germany

Location

Hospital Muenchen-Pasing

Munich, Bavaria, 81241, Germany

Location

Klinikum Nuernberg Sued Dpt. of Vascular Surgery

Nuremberg, Bavaria, 90471, Germany

Location

Krankenhaus Barmherzige Brüder, Dpt. of Vascular Surgery

Regensburg, Bavaria, 93049, Germany

Location

Klinik fuer Gefaesschirurgie St-Bonifatius-Hospital Lingen

Lingen, Lower Saxony, 49808, Germany

Location

Luisenhospital Dpt. of Vascular Surgery

Aachen, North Rhine-Westphalia, 50937, Germany

Location

Gefaesschirurgische Klinik St-Marienhospital Bonn

Bonn, North Rhine-Westphalia, 53115, Germany

Location

Knappschaftskrankenhaus Bottrop Dpt. of Vascular Surgery

Bottrop, North Rhine-Westphalia, 46242, Germany

Location

Clinic and Polyclinic for Vascular Surgery

Cologne, North Rhine-Westphalia, 50937, Germany

Location

Evangelisches Krankenhaus Dpt. of Vascular Surgery

Mülheim, North Rhine-Westphalia, 45468, Germany

Location

Sana Clinic Remscheid Dpt. of Vascular Surgery

Remscheid, North Rhine-Westphalia, 42859, Germany

Location

MeSH Terms

Conditions

Peripheral Arterial Disease; Peripheral Vascular Diseases

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2010
• First Posted: March 30, 2010
• Study Start: March 1, 2010
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: July 9, 2014

Record last verified: 2014-07

Locations

DE (12)