Clinical trial NCT06822322: The European Bifurcation Club Randomized Trial of Stepwise Provisional Stenting Versus Drug Coated Balloon Therapy for Non-left Main True Coronary Bifurcations
Official title: The European Bifurcation Club Randomized Trial of Stepwise Provisional Stenting Versus Drug Coated Balloon Therapy for Non-left Main True Coronary Bifurcations - EBC DCB Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Coronary Artery Disease (non-left Main)
Coronary Bifurcation Lesion
Keywords: non-left coronary bifurcation
drug coated balloon
drug eluted stent
Lead sponsor: Ceric Sàrl
Sponsor class: INDUSTRY
Collaborators: name: European Cardiovascular Research Center
First posted: 2025-02-12
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Post-market study to compare Drug Coated Balloon versus Drug Eluted Stent.
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Bifurcation Orientated Composite Endpoint (BOCE)
timeFrame: At 1-year, after the day of enrollment
Secondary outcomes:
measure: Bifurcation Orientated Composite Endpoint (BOCE)
timeFrame: At 3, 5 and 8-years
measure: Individual components of the Primary Endpoint
timeFrame: At 1, 3, 5 and 8-years
measure: Safety Composite Endpoint
timeFrame: At 1, 3, 5 and 8-years
measure: Individual components of the Safety Composite Endpoint
timeFrame: At 1, 3, 5 and 8-years
measure: BARC 3 or 5 bleeding rate
timeFrame: At 1, 3, 5 and 8-years
measure: Angina status
timeFrame: At 1, 3, 5 and 8-years
measure: Angina index
timeFrame: At 1, 3, 5 and 8-years
Other outcomes:
Locations:
Study officials:
affiliation: Brighton & Sussex University NHS Hospitals Trust - Royal Sussex County Hospital - Eastern Road - Brighton, East Sussex - BN25BE, United Kingdom
name: David HILDICK-SMITH, Prof., MD
role: PRINCIPAL_INVESTIGATOR
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