CELTIC Bifurcation Study

• Conditions: Coronary Bifurcations

• Registration Number: NCT02232815
• Lead Sponsor: European Cardiovascular Research Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-08-25
• Study First Submitted QC: 2014-09-03
• Study First Posted: 2014-09-05
• Study Start: 2014-12
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-06
• Last Update Posted: 2016-09-07
• Primary Completion: 2016-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 170

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite measure of Adverse events	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 Outcome Measures

Name	Time	Method
Need to use secondary equipment or manoeuvres to complete the case	Day 0, during procedure	extra support guidewires, anchor balloons or mother \& daughter catheter
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	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 \[14\])

Trial Locations

Locations (6)

Belfast Health & Social Care Trust; 🇬🇧 Belfast, United Kingdom

Bristol Royal Infirmary; 🇬🇧 Bristol, United Kingdom

Edinburgh Royal Infirmary; 🇬🇧 Edinburgh, United Kingdom

Golden Jubilee; 🇬🇧 Glasgow, United Kingdom

Kings College; 🇬🇧 London, United Kingdom

St Vincent's Hospital Dublin; 🇮🇪 Dublin, Ireland