Status:
COMPLETED
Prevention of Restenosis After Genous Stent Implantation Using a Paclitaxel Eluting Balloon in Coronary Arteries
Lead Sponsor:
University of Ulm
Collaborating Sponsors:
B. Braun Melsungen AG
OrbusNeich
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00732953
Start Date
February 1 2009
End Date
February 1 2014
Last Update
June 10 2014
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Klinikum Coburg
Coburg, Germany, 96450
2
University of Ulm
Ulm, Germany, 89081
3
Schwarzwald-Baar Klinikum
Villingen-Schwenningen, Germany, 78011