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RECRUITING
NCT05544864
NA

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

View on ClinicalTrials.gov

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

DEVICE

Drug eluting stent (DES)

DES-implantation with an everolimus-eluting stent (Xience, Abbott Vascular)

DEVICE

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