Peripheral Artery Disease Clinical Trial
Official title:
REAL PTX - Randomized Evaluation of the Zilver PTX Stent vs. Paclitaxel-Eluting Balloons for Treatment of Symptomatic Peripheral Artery Disease of the Femoropopliteal Artery
Objective of the REAL PTX trial is to compare paclitaxel-eluting stents to paclitaxel-eluting balloons for treating symptomatic peripheral artery disease of the femoropopliteal artery.
The REAL PTX trial has been designed as prospective, randomized, multi-center, post-market
study investigating the effect of the paclitaxel-eluting stent Zilver® PTX® (DES)in
comparison to the use of a paclitaxel eluting balloon (DEB)in treating symptomatic
peripheral artery disease of the femoropopliteal artery.
Up to 150 patients will be enrolled in Germany and Belgium. Enrollment is expected to be
completed within approximately six months of initiating the study.
One group (DES or DEB) will be considered to yield significantly better results of the
primary patency rate than the other group at 12 months follow up.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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