EBC DCB, Version 2.0, dated 14 May 2025
Research type
Research Study
Full title
The European Bifurcation Club randomized trial of stepwise provisional stenting versus Drug Coated Balloon Therapy for non-left main true coronary bifurcations
IRAS ID
355726
Contact name
David HILDICK-SMITH
Contact email
Sponsor organisation
Center for European Research Initiatives in Cardiovascular Medicine (CERIC)
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
Not applicable, Not applicable
Duration of Study in the UK
9 years, 11 months, 30 days
Research summary
The provisional one-stent strategy using drug-eluting stents (DES) is currently the preferred treatment approach for coronary bifurcation lesions, minimizing stent use and procedural complexity. Stent deployment in bifurcations is complex due to vessel size mismatches and plaque shifts, often resulting in malapposition, deformation, or compromised blood flow.
Drug-coated balloons (DCBs) offer a stent-free alternative, delivering anti-proliferative drugs (paclitaxel or sirolimus, for example) to prevent intimal hyperplasia.The EBC DCB study is a prospective, multicenter, investigator-initiated, open-label, randomized 1:1 non-inferiority trial comparing a DCB-only interventional strategy to progressive temporary implantation of a drug-eluting stent (DES) for the treatment of coronary bifurcation disease.
The study will use CE marked DCB and DES devices from the same manufacturer (Medtronic). All devices used in this clinical investigation will be utilized in compliance with their approved Instructions for Use and in accordance with standard clinical practice.
The main objective of this study is to determine whether DCB treatment of narrowing at a coronary bifurcation is non-inferior in terms of clinical outcomes to a stepwise provisional stenting strategy with deployment of DES followed by a non-compliant (kissing balloon treatment) at 1 year.
The target population for this clinical investigation includes adult patients with non-left main coronary bifurcation lesions requiring revascularization. Eligible patients must present with a significant lesion in the main vessel and side branch, confirmed by angiographic assessment.
The clinical study will involve approximately 750 patients, about 320 patients in the UK, at 20 investigation sites in Europe (including 4 in the UK) and South Korea.
Follow-up examinations will be conducted in accordance with the usual practices of participating hospitals. The period of patient inclusion is estimated at 24 months, with follow-up appointments at 6 months, 1 year, 3 years, 5 years, and 8 years post-procedure. The total duration of patient participation is 8 years.
REC name
South East Scotland REC 02
REC reference
25/SS/0057
Date of REC Opinion
2 Sep 2025
REC opinion
Further Information Favourable Opinion