Drug-Coated Balloon in Anticoagulated and Bleeding Risk Patients Undergoing PCI

Recruiting N/A Interventional Study
Coronary Artery Disease
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
546 (estimated)
Sponsor
North Karelia Central Hospital · Other
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About This Trial
The purpose of this study is to compare DCB with DES in stable CAD or ACS patients who are at high risk of bleeding. The hypothesis of the DEBATE trial is that the strategy using DCB and a shorter DAPT regimen is non-inferior to the treatment using DES and longer DAPT duration on patients with high bleeding risk. If non-inferiority is shown, the superiority of the DCB strategy over DES strategy wi…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Age ≥ 18 years * Informed written consent * At least one major or two minor bleeding risk criteria of Academic Research Consortium (ARC) Major Criteria * Long-term oral anticoagulation * Severe or end stage chronic kidney disease (CKD) (estimated glomerular - filtration rate…
Contacts

Tuomas Rissanen, MD, PhD

+358505998022

tuomas.rissanen@siunsote.fi

CONTACT

Alma Räsänen, MD

alma.rasanen@siunsote.fi

CONTACT