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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCeric Sàrl

About this trial

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.

Eligibility criteria

Qualifiers

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

≥70% angiographic MV and SB diameter stenosis

Positive non-invasive testing for ischaemia

Positive coronary physiology for ischaemia

Disqualifiers

Patients <18 years old

STEMI <48 hours

Cardiogenic shock

Chronic total occlusion involving target bifurcation vessels

Trial design

Treatments tested in this trial

  • Percutaneous Coronary Angioplasty
  • Stepwise Provisional Stent Strategy
  • Drug Coated Balloon Strategy
  • Cross-Over Stepwise Provisional Stent Strategy

Treatment groups

750 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Ceric Sàrl

Lead sponsor

European Cardiovascular Research Center

Collaborator