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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2014-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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1

Genous stent implantation with paclitaxel-eluting balloon therapy

Group Type ACTIVE_COMPARATOR

Genous stent implantation with paclitaxel-eluting balloon dilation

Intervention Type DEVICE

Genous stent implantation with paclitaxel-eluting balloon therapy

2

Genous stent implantation

Group Type ACTIVE_COMPARATOR

Genous stent implantation

Intervention Type DEVICE

Genous stent implantation

Interventions

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Genous stent implantation with paclitaxel-eluting balloon dilation

Genous stent implantation with paclitaxel-eluting balloon therapy

Intervention Type DEVICE

Genous stent implantation

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No