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

Study 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.

Official Title
-----------------
Prevention of Restenosis After Genous Stent Implantation Using a Paclitaxel Eluting Balloon in Coronary Arteries - a Randomized Clinical Trial.

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Device: Genous stent implantation with paclitaxel-eluting balloon dilation
* Device: Genous stent implantation


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Genous stent implantation with paclitaxel-eluting balloon therapy | Device: Genous stent implantation with paclitaxel-eluting balloon dilation<br>* Genous stent implantation with paclitaxel-eluting balloon therapy<br>|
| Active Comparator: 2<br>Genous stent implantation | Device: Genous stent implantation<br>* Genous stent implantation<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Late loss |  | 6 months | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
patients with coronary artery disease, percutaneous coronary intervention, stent implantation, paclitaxel eluting balloon, angiographic follow-up, clinical follow-up