Peripheral Arterial Disease Clinical Trial
Official title:
Paclitaxel Coated Balloon Catheter for Inhibition of Restenosis in Femoropopliteal Arteries (PACCOCATH - FEM I)
The PACCOCATH FEM study is a randomized, double-blinded German multicenter trial on the efficacy and tolerance of a paclitaxel coated balloon catheter in prevention of restenosis after femoropopliteal angioplasty.
Background: Treatment of patients with peripheral arterial disease (PAD) in the
femoropopliteal arteries by percutaneous intervention is still limited by high rates of
restenosis. The aim of the present study is to evaluate the efficacy and safety of a novel
method of short time local drug delivery based on a paclitaxel-coated balloon in
femoropopliteal arteries.
Methods and results: The double-blind and randomized study enrolled n=79 patients with
occlusion or stenosis of femoropopliteal arteries. Inclusion criteria were clinical
Rutherford stage 1-5, occlusion or hemodynamic relevant stenosis (≥ 70 % diameter) of
femoropopliteal arteries and successful guiding wire recanalization. The primary endpoint
was the late lumen loss after 6 months follow-up as seen in angiography. Secondary endpoints
included the rate of restenosis (a binary variable), change of ankle brachial index (ABI),
rutherford class and major adverse events.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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