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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by NonWoTecc Medical GmbH.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
MDT Medical Device Testing GmbH
Information provided by:
NonWoTecc Medical GmbH
ClinicalTrials.gov Identifier:
NCT01095237
First received: March 23, 2010
Last updated: June 30, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention
Peripheral Arterial Disease
Peripheral Vascular Disease
Device: ProEndoTecc Vascular Graft

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicenter, Clinical Pilot-Study of ProEndoTecc Vascular Grafts (6, 7 or 8 mm Diameter) as Superficial Femoral Artery Bypass/Interponate

Resource links provided by NLM:


Further study details as provided by NonWoTecc Medical GmbH:

Primary Outcome Measures:
  • Primary patency of device [ Time Frame: 6, 12, 24 months after implatation ] [ Designated as safety issue: No ]

    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:
  • Guarding Safety variables [ Time Frame: 6,12, 24 months after implantation ] [ Designated as safety issue: Yes ]
    • Peri-interventional monitoring resp. haemorrhages, haematomas
    • Aneurysm in the grafted segment
    • Fistula to the grafted segment
    • Fibrosis at and around implantation site
    • Death


Enrollment: 33
Study Start Date: March 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: ProEndoTecc Vascular Graft
    Implantation of the device as an interponate / bypass of the superficial femoral artery
    Other Name: ProEndoTecc Vascular Graft Prosthesis
  Eligibility

Ages Eligible for Study:   18 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01095237

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

No publications provided

Responsible Party: Dr. Stefanie Kaempf, Medical Manager, NonWoTecc medical GmbH
ClinicalTrials.gov Identifier: NCT01095237     History of Changes
Other Study ID Numbers: mdt-09k006
Study First Received: March 23, 2010
Last Updated: June 30, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by NonWoTecc Medical GmbH:
Peripheral Arterial Disease
Peripheral Vascular Disease
PAD
vascular prosthesis
revascularization
patency
blood vessel
Rutherford
ABI
Ankle Brachial Index
Vascular Graft
Carbothane
ProEndoTecc
implantation

Additional relevant MeSH terms:
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on April 21, 2014