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Intracoronary Stenting and Restenosis - Randomized Trial of Drug-eluting Stent Implantation or Drug-coated Balloon Angioplasty According to Neointima Morphology in Drug-eluting Stent Restenosis 5
Sponsor: Deutsches Herzzentrum Muenchen
Summary
The hypothesis of the study is, that there is a significant interaction in treatment effect between the OCT pattern of neointima (heterogeneous or homogeneous) and the type of percutaneous coronary intervention (drug-eluting stent or drug-coated balloon) in patients with in-stent restenosis.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
376
Start Date
2022-09-28
Completion Date
2026-09
Last Updated
2025-01-06
Healthy Volunteers
No
Interventions
Drug eluting stent (DES)
DES-implantation with an everolimus-eluting stent (Xience, Abbott Vascular)
Drug coated ballloon (DCB)
DCB angioplasty with any commercially available drug-coated balloon
Locations (5)
Universitätsklinikum Frankfurt
Frankfurt am Main, Hesse, Germany
Elisabeth-Krankenhaus Essen GmbH
Essen, Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany
Deutsches Herzzentrum München
Munich, Germany
Hospital Universitario de La Princesa Madrid
Madrid, Madrid, Spain