Femoral Artery Occlusion Clinical Trial
Official title:
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
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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