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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
120
Genous stent implantation with paclitaxel-eluting balloon therapy
Genous stent implantation
Klinikum Coburg
Coburg, Germany
University of Ulm
Ulm, Germany
Schwarzwald-Baar Klinikum
Villingen-Schwenningen, Germany
Late loss
Time frame: 6 months
Diameter stenosis
Time frame: 6 months
Binary restenosis rate
Time frame: 6 month
Late loss index
Time frame: 6 months
Target lesion revascularization
Time frame: 2, 6, 12, 24, 36, 48, 60 months
Target vessel revascularization
Time frame: 2, 6, 12, 24, 36, 48, 60 months
Major adverse cardiac events
Time frame: 2, 6, 12, 24, 36, 48, 60 months
Stent thrombosis
Time frame: 2, 6, 12, 24, 36, 48, 60 months
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