NCT01728441

Evaluation of Paclitaxel Eluting Stent vs Paclitaxel Eluting Balloon Treating Peripheral Artery Disease of the Femoral Artery

REAL PTX - Randomized Evaluation of the Zilver PTX Stent vs. Paclitaxel-Eluting Balloons for Treatment of Symptomatic Peripheral Artery Disease of the Femoropopliteal Artery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Provascular GmbH · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Peripheral Artery Disease

Interventions

Type	Name	Description
DEVICE	Paclitaxel Eluting Stent
DEVICE	Paclitaxel Eluting Balloon

Timeline

• Start date: 2012-10-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2012-11-19
• Last updated: 2014-05-20

Locations

5 sites across 2 countries: Belgium, Germany