CELTIC Bifurcation Study

European Cardiovascular Research Institute (ECRI)

Status: Unknown

Conditions: Coronary Bifurcations

Study type: Observational

Funder types: NETWORK; Industry

Identifiers

NCT02232815

BSC-02

Details and patient eligibility

About

This study will examine outcomes for patients treated by planned culotte stenting and compare outcomes with 2 different stent platforms, the next generation Synergy II and the Xience Xpedition DES platforms.

Enrollment: 170 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female patient >18 years old
• Females of childbearing potential with a negative pregnancy test
• Coronary artery disease requiring revascularization that is amenable to PCI
• Medina 1,1,1 bifurcation lesion [13] with >70% lesion in both the main vessel and the side branch by visual assessment
• Main branch and side branch ≥ 2.5mm in diameter by visual assessment
• Both vessels require stenting in the opinion of the operator

Exclusion criteria

• Acute myocardial infarction with ongoing ST-elevation
• Cardiogenic shock
• Lesion involves the left main coronary artery
• Lesion involves bypass graft
• Plan to treat >1 other coronary vessel at the time of inclusion
• Chronic total occlusion of any target vessel
• Left ventricular ejection fraction <20%
• Requirement for ongoing haemodialysis
• Life-expectancy limited to <12 months due to co-morbid condition
• Known allergy to Aspirin
• Known allergy to Clopidorel and Prasugrel and Ticagrelor
• Known allergy to stent drug elutant
• Known allergy to any other component of either the Synergy II or Xience Xpedition stents systems
• Ongoing participation in another investigational device or drug study
• Inability to provide informed consent