Prevention of Restenosis After Genous Stent Implantation Using a Paclitaxel Eluting Balloon in Coronary Arteries - a Randomized Clinical Trial.
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Coronary Artery Disease
- Sponsor
- University of Ulm
- Enrollment
- 120
- Locations
- 3
- Primary Endpoint
- Late loss
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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.
Investigators
Jochen Wohrle
Prof. Dr. Jochen Wöhrle
University of Ulm
Eligibility Criteria
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
Outcomes
Primary Outcomes
Late loss
Time Frame: 6 months
Secondary Outcomes
- 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)