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

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00732953

Enrollment

120

Registered

2008-08-12

Start date

2009-02-28

Completion date

2014-02-28

Last updated

2014-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

patients with coronary artery disease, percutaneous coronary intervention, stent implantation, paclitaxel eluting balloon, angiographic follow-up, clinical follow-up

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.

Interventions

DEVICEGenous stent implantation with paclitaxel-eluting balloon dilation

Genous stent implantation with paclitaxel-eluting balloon therapy

DEVICEGenous stent implantation

Genous stent implantation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Late loss	6 months

Secondary

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 29, 2026