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Drug-coated Balloons Versus Drug-eluting Stents for de Novo Small-vessel Coronary Artery Disease
Sponsor: National and Kapodistrian University of Athens
Summary
This prospective, multicenter observational study will compare the safety and clinical outcomes of drug-coated balloon angioplasty and second-generation drug-eluting stent implantation in patients undergoing percutaneous coronary intervention for previously untreated lesions in small coronary vessels. The treatment strategy will be selected by the treating interventional cardiologist according to the patient's clinical and angiographic characteristics and will not be assigned randomly by the study. Participants will receive standard clinical care and will be followed for 12 months. The study will evaluate major adverse cardiovascular events, including cardiovascular death, myocardial infarction, and the need for repeat treatment of the target lesion. Procedural outcomes and treatment-related complications will also be recorded.
Official title: Drug-Coated Balloons Versus Drug-Eluting Stents for De Novo Small-Vessel Coronary Artery Disease: A Prospective, Multicenter, Non-Randomized Observational Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
230
Start Date
2024-10-03
Completion Date
2027-10-03
Last Updated
2026-09-24
Healthy Volunteers
No
Conditions
Interventions
Drug coated balloon
Percutaneous coronary intervention performed using a drug-coated balloon following adequate lesion preparation. Balloon type, diameter, length, inflation pressure, and inflation duration are selected by the treating interventional cardiologist according to lesion characteristics and routine clinical practice. Bailout stent implantation may be performed when clinically required, including in cases of significant residual stenosis, impaired coronary flow, or flow-limiting dissection.
Drug Eluting stent
Percutaneous coronary intervention performed using a second-generation drug-eluting stent following lesion preparation. Stent type, diameter, length, implantation pressure, and post-dilatation strategy are selected by the treating interventional cardiologist according to lesion characteristics and routine clinical practice.
Locations (1)
First Department of Cardiology, Medical School of Athens, National and Kapodistrian University of Athens, General Hospital of Athens Ippokrateio, Athens, Greece
Athens, Attica, Greece