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

Phase 2

Completed

• Conditions: Coronary Artery Disease
• Interventions: Device: Genous stent implantation with paclitaxel-eluting balloon dilation; Device: Genous stent implantation

• Registration Number: NCT00732953
• Lead Sponsor: University of Ulm

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-08-07
• Study First Submitted QC: 2008-08-08
• Study First Posted: 2008-08-12
• Study Start: 2009-02
• Primary Completion: 2010-01
• Study Completion: 2014-02
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-07
• Last Update Posted: 2014-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• patients >18 years old
• lesion in native coronary artery
• de-novo stenosis
• indication for revascularization (angina status, myocardial ischemia, positive stress test, pathologic FFR)
• range of reference diameter 2.5 to 4.0mm

Exclusion Criteria

• lesion in saphenous vein graft
• chronic total occlusion
• bifurcation lesion requiring stenting of main and side branch
• left main stenosis
• restenosis
• in-Stent restenosis
• contraindication for dual antiplatelet therapy for the following 6 months
• coronary aneurysm in target vessel

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Genous stent implantation with paclitaxel-eluting balloon dilation	Genous stent implantation with paclitaxel-eluting balloon therapy
2	Genous stent implantation	Genous stent implantation

Primary Outcome Measures

Name	Time	Method
Late loss	6 months

Secondary Outcome Measures

Name	Time	Method
Binary restenosis rate	6 month
Diameter stenosis	6 months
Stent thrombosis	2, 6, 12, 24, 36, 48, 60 months
Late loss index	6 months
Target vessel revascularization	2, 6, 12, 24, 36, 48, 60 months
Target lesion revascularization	2, 6, 12, 24, 36, 48, 60 months
Major adverse cardiac events	2, 6, 12, 24, 36, 48, 60 months

Trial Locations

Locations (3)

Klinikum Coburg; 🇩🇪 Coburg, Germany

University of Ulm; 🇩🇪 Ulm, Germany

Schwarzwald-Baar Klinikum; 🇩🇪 Villingen-Schwenningen, Germany