In this multicentre Randomized Clinical Trial, the heparin-bonded endoluminal bypass will be compared to the surgical venous femoro-popliteal bypass, based on the non-inferiority principle for the patency. Besides equal patency, an improved quality of life is expected. Recruitment will take the first two years and patients will be followed during five years. Patients with an indication for surgical bypass, classified category 3-6 with a \>50% stenosis or occlusion of the SFA over \>/=10 cm in length will be included. At least one crural artery should be patent without significant lesions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
129
Heparin-bonded ePTFE endoluminal femoropopliteal bypass versus surgical femoropopliteal bypass
Surgical femoro-popliteal bypass.
Rijnstate Hospital
Arnhem, Gelderland, Netherlands
Slingeland Hospital
Doetinchem, Gelderland, Netherlands
Isala klinieken
Zwolle, Overijssel, Netherlands
Nij Smellinghe Hospital
Drachten, Provincie Friesland, Netherlands
Primary (and -assisted) patency
Time frame: 5 years
Quality of life
Time frame: 5 years
Secondary patency
Time frame: 5 years
Complications
Time frame: 5 years
Clinical improvement
Time frame: 5 years
Re-intervention
Time frame: 5 years
Target lesion revascularisation
Time frame: 5 years
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Antonius Hospital
Sneek, Provincie Friesland, Netherlands
University Medical Centre Groningen
Groningen, Netherlands