A Randomized Multicentre Trial to Compare Outcomes for Patients With Ischaemic Heart Disease and Bifurcation Coronary Artery Lesions Who Are Treated With Xience or Synergy Stents

European Cardiovascular Research Center6 sites in 2 countries170 target enrollmentDecember 2014

ConditionsCoronary Bifurcations

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Coronary Bifurcations
Sponsor: European Cardiovascular Research Center
Enrollment: 170
Locations: 6
Primary Endpoint: Composite measure of Adverse events
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

December 2014

End Date

December 2018

Last Updated

9 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

European Cardiovascular Research Center

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Composite measure of Adverse events

Time Frame: 9 months

Composite of: * Death * Myocardial Infarction * CVA * Target Vessel Failure (Composite of Target Vessel Revascularization and Target Vessel Inadequacy) * Definite or Probable stent thrombosis (ARC criteria \[14\]) * Binary angiographic restenosis

Secondary Outcomes

Need to use secondary equipment or manoeuvres to complete the case(Day 0, during procedure)
Evidence of longitudinal stent compression at index implantation(Day 0, during procedure)
Technical success (deployment of stents in both branches with <20% residual stenosis and kissing balloon inflation at end of procedure)(Day 0, during procedure)
Total procedure time(Day 0, during procedure)
Total radiation dose(Day 0, during procedure)
Evidence of stent fracture at angiographic follow-up(Day 0, during procedure)
Composite measure of Adverse events(24 months)