RecruitingNot ApplicableNCT05544864

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

Enrollment

376 participants

Start Date

Sep 28, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Drug coated ballloon (DCB) and a medical device called Drug eluting stent (DES) for people with coronary artery disease and restenoses, coronary. The study is currently recruiting participants at 5 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEDrug eluting stent (DES)

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

DEVICEDrug 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

View Full Details on ClinicalTrials.gov

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NCT05544864


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