Drug Coated Balloon vs. Drug-eluting Stent in Patients With Coronary Artery Disease
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorSamsung Medical Center
About this trial
Studies exploring the feasibility of drug-eluting balloon (DCB) in de-novo coronary lesions are limited. There are scarce data comparing DCB with drug-eluting stent (DES) in patients with high bleeding risk (HBR), a situation in which long-term maintenance of dual antiplatelet therapy (DAPT) is a clinical dilemma. This target trial emulation aims to compare clinical outcomes between DCB angioplasty and conventional DES implantation in de-novo coronary lesions in patients with coronary artery disease.
Eligibility criteria
Qualifiers
Patients with coronary artery disease undergoing percutaneous coronary intervention
Used devices number less than three (relatively simple lesion)
Disqualifiers
Hybrid strategy (DCB and DES use)
Failed percutaneous coronary intervention
Previous revascularization procedure before index percutaneous coronary intervention
Trial design
Treatments tested in this trial
- Drug coated balloon
- Drug-eluting stent
Treatment groups
470,000 Participants
are divided into 2 treatment groupsLocations
1Samsung Medical Center06351, Seoul South Korea
Sponsors and collaborators
Samsung Medical Center
Lead sponsor
Source ClinicalTrials.gov