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NCT06822322Not yet recruiting

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

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

Source: ClinicalTrials.gov · Last updated 14 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
750 (estimated)
First submitted
23 Jan 2025
Start date
May 2025
Primary completion date
May 2028
Lead sponsor
Ceric Sàrl
NCT number
NCT06822322

What you commit to

  • Study type: Interventional
  • Planned participants: 750
  • From May 2025 to the primary completion date, May 2028
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Participation in another investigational drug or device study

Lab values

  • Platelet count ≤50x109/mm3
  • Left ventricular ejection fraction ≤20%

Age

  • Patients \<18 years old

Other

  • 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
  • Patient unable to give informed consent

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.