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

NCT01095237 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2014-07-09

No results posted yet for this study

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

Interventions

DEVICE

ProEndoTecc Vascular Graft

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

Sponsors & Collaborators

  • MDT Medical Device Testing GmbH

    collaborator INDUSTRY

  • NonWoTecc Medical GmbH

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2012-11-30
Completion
2012-11-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01095237 on ClinicalTrials.gov