NCT00732953

Prevention of Restenosis After Genous Stent Implantation Using a Paclitaxel Eluting Balloon in Coronary Arteries

Prevention of Restenosis After Genous Stent Implantation Using a Paclitaxel Eluting Balloon in Coronary Arteries - a Randomized Clinical Trial.

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: University of Ulm · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Percutaneous coronary intervention with stent implantation is limited on the one hand by restenosis due to smooth muscle cell proliferation and on the other hand by stent thrombosis due to incomplete or not sufficient enough endothelialization of stent struts. The Genous stent implantation allows a rapid layer over the stent struts with endothelial progenitor cells allowing a fast endothelialization and probably reducing the risk of stent thrombosis. Local therapy with drug-eluting balloons administering paclitaxel has been shown to reduce restenosis in in-stent restenosis and de-novo lesions in vessels with small reference diameter. The combination of a paclitaxel-eluting balloon and Genous stent implantation may summarized both advantages: a rapid endothelialization limiting the number of stent thrombosis and on the other hand a reduction of smooth muscle cell proliferation minimizing the risk of restenosis with the subsequent need for revascularization.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	Genous stent implantation with paclitaxel-eluting balloon dilation	Genous stent implantation with paclitaxel-eluting balloon therapy
DEVICE	Genous stent implantation	Genous stent implantation

Timeline

• Start date: 2009-02-01
• Primary completion: 2010-01-01
• Completion: 2014-02-01
• First posted: 2008-08-12
• Last updated: 2014-06-10

Locations

3 sites across 1 country: Germany