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

Multicenter, Clinical Pilot-Study of ProEndoTecc Vascular Grafts (6, 7 or 8 mm Diameter) as Superficial Femoral Artery Bypass/Interponate

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 Overview

• Status: Terminated
• Conditions: Peripheral Arterial Disease; Peripheral Vascular Disease
• Intervention / Treatment: Device: ProEndoTecc Vascular Graft

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Baden-Wuerttemberg
    • Karlsruhe, Baden-Wuerttemberg, Germany, 76133
      • Staedtisches Klinikum Karlsruhe gGmbH
  • Bavaria
    • Deggendorf, Bavaria, Germany, 94469
      • Klinikum Deggendorf, Dpt. of Vascular- and Endovascular Surgery
    • Muenchen, Bavaria, Germany, 81241
      • Hospital Muenchen-Pasing
    • Nuernberg, Bavaria, Germany, 90471
      • Klinikum Nuernberg Sued Dpt. of Vascular Surgery
    • Regensburg, Bavaria, Germany, 93049
      • Krankenhaus Barmherzige Brüder, Dpt. of Vascular Surgery
  • Lower Saxony
    • Lingen, Lower Saxony, Germany, 49808
      • Klinik fuer Gefaesschirurgie St-Bonifatius-Hospital Lingen
  • Nordrhein-Westfalen
    • Aachen, Nordrhein-Westfalen, Germany, 50937
      • Luisenhospital Dpt. of Vascular Surgery
    • Bottrop, Nordrhein-Westfalen, Germany, 46242
      • Knappschaftskrankenhaus Bottrop Dpt. of Vascular Surgery
    • Cologne, Nordrhein-Westfalen, Germany, 50937
      • Clinic and Polyclinic for Vascular Surgery
    • Muelheim, Nordrhein-Westfalen, Germany, 45468
      • Evangelisches Krankenhaus Dpt. of Vascular Surgery
    • Remscheid, Nordrhein-Westfalen, Germany, 42859
      • Sana Clinic Remscheid Dpt. of Vascular Surgery
  • North Rhine-Westphalia
    • Bonn, North Rhine-Westphalia, Germany, 53115
      • Gefaesschirurgische Klinik St-Marienhospital Bonn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6,12, 24 months after implantation

Collaborators and Investigators

• Sponsor: NonWoTecc Medical GmbH
• Collaborators: MDT Medical Device Testing GmbH

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (ACTUAL): November 1, 2012
• Study Completion (ACTUAL): November 1, 2012

Study Registration Dates

• First Submitted: March 23, 2010
• First Submitted That Met QC Criteria: March 29, 2010
• First Posted (ESTIMATE): March 30, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): July 9, 2014
• Last Update Submitted That Met QC Criteria: July 8, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: PAD; Peripheral Vascular Disease; revascularization; Peripheral Arterial Disease; Ankle Brachial Index; implantation; ABI; blood vessel; patency; Vascular Graft; vascular prosthesis; Rutherford; Carbothane; ProEndoTecc
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Vascular Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: mdt-09k006