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Pressure-wire Guided PTCA: Drug Eluting Stent Versus Drug Eluting Balloon (WinDEB Study)

Coronary Artery Disease Clinical Trial

Official title:
Pressure Wire-guided Percutaneous Coronary Intervention of Small Vessels or Side Branches: Functional Outcome of Drug-Eluting Stent (DES) Versus Drug-Eluting Balloon (DEB) With Provisional Bare Metal Stent Implantation

Clinical Trial Summary

The aim of the study is to show the safety and efficacy of the SeQuent® Please (Drug Eluting Balloon or DEB) vs. commonly used Drug Eluting Stents in the treatment of small vessel disease and side branches by pressure wire guided percutaneous coronary intervention.

Clinical Trial Description

This study is a randomized, prospective, multi-center, efficacy study with a DES control group assessing the 6-month loss in FFR in patients treated with the "matrix coated paclitaxel-eluting PTCA-balloon catheter" SeQuent® Please and commonly used DES for small vessel de novo and side branch lesions. 100 patients will be studied in total with two equivalent treatment groups DEB & DES of 50 patients each. ;

Study Design

Intervention Model: Parallel Assignment, Masking: Single Blind

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01399463
Study type Interventional
Source Medical University of Vienna
Contact
Status Not yet recruiting
Phase N/A
Start date August 2011
View Details
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