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Bypass or Thurpass for Superficial Femoral Artery Occlusion? Scandinavian Thurpass Study

NCT00810134 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2008-12-17

No results posted yet for this study

Summary

The aim of the study is to compare PTFE-graft bypass surgery versus Viabahn endoprosthesis for femoropopliteal arterial occlusion in intermittent claudication and critical ischaemia in patients who would be technically amenable for both treatments. The primary objective is to compare primary patencies of the two treatments. The secondary objective of the study is to evaluate secondary patency, functional status, the quality of life and costs of the new endovascular therapy.

Conditions

  • Femoral Artery Occlusion

Interventions

PROCEDURE

Thrupass

Endovascular treatment (Thrupass) is performed as a femoropopliteal above knee endovascular recanalisation and Viabahn introduction with 6-7 mm Viabahn endo-prosthesis.

PROCEDURE

Bypass

Surgical procedure is performed as a femoropopliteal above knee by-pass with 6 mm non-coated PTFE-graft

Sponsors & Collaborators

  • W.L.Gore & Associates

    collaborator INDUSTRY

  • University of Helsinki

    lead OTHER

Principal Investigators

  • Mauri Lepantalo, M.D., PhD · Department of Vascular Surgery, Helsinki University Central Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-01-31
Primary Completion
2008-02-29
Completion
2008-04-30

Countries

  • Finland

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 NCT00810134 on ClinicalTrials.gov