CELTIC Bifurcation Study

Study 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.

Official Title
-----------------
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

Conditions
-----------------
Coronary Bifurcations

Participation Criteria
=================
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 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite measure of Adverse events | 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 | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Need to use secondary equipment or manoeuvres to complete the case | extra support guidewires, anchor balloons or mother & daughter catheter | Day 0, during procedure | 
| Evidence of longitudinal stent compression at index implantation |  | Day 0, during procedure | 
| Evidence of stent fracture at angiographic follow-up |  | Day 0, during procedure | 
| Composite measure of Adverse events | 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]) | 24 months |