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

University of Ulm

Status and phase: Completed; Phase 3; Phase 2

Conditions: Coronary Artery Disease

Treatments: Device: Genous stent implantation; Device: Genous stent implantation with paclitaxel-eluting balloon dilation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00732953

UULM-JW-GP

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

1

Active Comparator group

Description:

Genous stent implantation with paclitaxel-eluting balloon therapy

Treatment:

Device: Genous stent implantation with paclitaxel-eluting balloon dilation

2

Active Comparator group

Description:

Genous stent implantation

Treatment:

Device: Genous stent implantation