NCT00810134

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

A Randomised Controlled Trial for the Treatment of 5 - 25 cm Superficial Femoral Artery oc-Clusions Comparing Femoropopliteal Bypass With 6 mm PTFE-Prosthesis and 6 - 7 mm Viabahn Endoprosthesis

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: University of Helsinki · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Femoropopliteal bypass graft surgery with PTFE-prosthesis has proven to be an acceptable treatment for stable incapacitating claudication and critical ischaemia in patients with superficial femoral artery occlusion. Preliminary results of a thrupass endoprosthesis in the treatment of femoral lesions are promising. Less morbidity and better cost-effectiveness are suggested to be achieved in treatment of chronic lower limb ischaemia with endovascular treatment comparing to surgical treatment. A randomised multicentre trial aims to enrol a pilot group of 60 + 60 patients to be followed for 3 years. Patients are treated either with Viabahn thrupass endoprosthesis (Gore corp.) or with 6 mm PTFE-prosthesis bypass graft surgery. Primary patency at three years is the primary end point and secondary patency, functional success, costs and quality of life are the secondary end points.

Conditions

• Femoral Artery Occlusion

Interventions

Type	Name	Description
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

Timeline

• Start date: 2003-01-01
• Primary completion: 2008-02-01
• Completion: 2008-04-01
• First posted: 2008-12-17
• Last updated: 2008-12-17

Locations

1 site across 1 country: Finland