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
Locations
Sponsors and collaborators
Ceric Sàrl
Lead sponsor
European Cardiovascular Research Center
Collaborator