The European Bifurcation Club Randomized Trial of Stepwise Provisional Stenting Versus Drug Coated Balloon Therapy for Non-left Main True Coronary Bifurcations

Not Applicable

Not yet recruiting

• Conditions: Coronary Artery Disease (non-left Main); Coronary Bifurcation Lesion

• Registration Number: NCT06822322
• Lead Sponsor: Ceric Sàrl

Brief Summary

Clinical outcomes are worse in patients with coronary artery bifurcation lesions, even if commonly encountered in clinical practice. The use of drug coated balloons within bifurcation lesions offers the acute advantage of a more straightforward procedure, without recrossing and deformation of a stent. Thus, the primary objective of this study is to determine if Drug Coated Balloon treatment of non-left main true coronary artery bifurcation lesions is non-inferior (similar) to a provisional strategy with Drug Eluted Stent deployment.

Detailed Description

The EBC DCB study is an investigator-initiated, prospective, multi-centre, open-label, randomized (1:1) non-inferiority trial.

Patients with non-left main bifurcations requiring revascularisation and both the main vessel and side branch significantly diseased ( ≥2.5mm and Medina 1/1/1, 1/0/1 or 0/1/1), constitute the source population. Patients with no more than two additional coronary disease may be considered for the study, with only one bifurcation lesion included.

Patients, pre-selected by their referring physicians, will be screened for eligibility by the study team. If patients fulfill all inclusion and do not meet exclusion criteria, they will be informed about the study's purpose and course and will be asked for participation and written informed consent. 20 sites will be involved, in 7 European countries and South Korea, for a total of 750 patients. After a 2-years recruitment period, the trial will include a Follow-Up period at 6-months, 1-year, 3-years, 5-years and 8-years. The 1-year check point will constitute the primary endpoint where the Bifurcation Orientated Composite Endpoint (BOCE) will be analyzed for non-inferiority (further analysis for superiority, if non-inferiority met).

Study Timeline

• Study First Submitted: 2025-01-23
• Status Verified: 2025-02
• Study First Submitted QC: 2025-02-06
• Study First Posted: 2025-02-12
• Last Update Submitted: 2025-02-13
• Last Update Posted: 2025-02-14
• Study Start: 2025-05
• Primary Completion: 2028-05
• Study Completion: 2035-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 750

Inclusion Criteria

• True non-left main bifurcation disease with both MV and SB involvement (i.e Medina 1/1/1, 1/0/1, 0/1/1)

• Bifurcation lesion responsible for an acute or chronic coronary syndrome with at least one of the following:

  • ≥70% angiographic MV and SB diameter stenosis
  • Positive non-invasive testing for ischaemia
  • Positive coronary physiology for ischaemia

• Significant SB as described by diameter stenosis ≥50% and all of the following:

  • SB length ≥73mm
  • SB diameter ≥2.5mm
  • Absence of another SB emerging distally from the MV
  • Non-dominant circumflex artery, if SB is a diagonal branch.

Exclusion criteria

• Patients <18 years old
• STEMI <48 hours
• Cardiogenic shock
• Chronic total occlusion involving target bifurcation vessels
• In-stent restenosis
• Patient life expectancy <12 months
• >2 other coronary lesions (target or non-target) planned for treatment
• SYNTAX score >32
• Platelet count ≤50x109/mm3
• Left ventricular ejection fraction ≤20%
• Participation in another investigational drug or device study
• Patient unable to give informed consent

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Bifurcation Orientated Composite Endpoint (BOCE)	At 1-year, after the day of enrollment	The BOCE is defined by: * cardiovascular death,; * target bifurcation-related myocardial infarction or; * target bifurcation revascularisation

Secondary Outcome Measures

Name	Time	Method
Individual components of the Primary Endpoint	At 1, 3, 5 and 8-years	* cardiovascular death; * target bifurcation-related myocardial infarction; * target bifurcation revascularisation
Individual components of the Safety Composite Endpoint	At 1, 3, 5 and 8-years	* BARC bleeding (2/3/5); * Definite stent/lesion thrombosis; * Stroke; * MI; * All-cause mortality
BARC 3 or 5 bleeding rate	At 1, 3, 5 and 8-years	BARC 3 or 5 bleeding rate
Safety Composite Endpoint	At 1, 3, 5 and 8-years	- Safety Composite Endpoint defined as: * BARC bleeding (2/3/5); * Definite stent/lesion thrombosis; * Stroke; * MI; * All-cause mortality
Angina status	At 1, 3, 5 and 8-years	Questionnaire: Seattle Angina Questionnaire - 7 (SAQ-7) Scale Range (Minimum and Maximum Values): 0 to 100 Higher scores indicate a better outcome (better health status, less angina, and better quality of life).
Angina index	At 1, 3, 5 and 8-years	No. of antianginals
Bifurcation Orientated Composite Endpoint (BOCE)	At 3, 5 and 8-years	BOCE non-inferiority and superiority