CELTIC Bifurcation Study

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

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.

Study Overview

• Status: Unknown
• Conditions: Coronary Bifurcations

• Study Type: Observational
• Enrollment (Anticipated): 170

Contacts and Locations

• Study Contact: Name: David Foley; Phone Number: +35 1 809 3140

Study Locations

• Ireland
  • Dublin, Ireland, 4
    • Recruiting
    • St Vincent's Hospital Dublin
    • Contact: Niall Mulvahill, Dr
    • Principal Investigator: Niall Mulvahill, Dr
• United Kingdom
  • Belfast, United Kingdom, BT8 8BH
    • Recruiting
    • Belfast Health & Social Care Trust
    • Contact: Colm Hanratty, Dr
    • Principal Investigator: Colm Hanratty, Dr
  • Bristol, United Kingdom, BS2 8HW
    • Recruiting
    • Bristol Royal Infirmary
    • Contact: Tom Johnson, Dr
    • Principal Investigator: Tom Johnson, Dr
  • Edinburgh, United Kingdom, EH16 4SA,
    • Recruiting
    • Edinburgh Royal Infirmary
    • Contact: Nick Cruden
    • Principal Investigator: Nick Cruden
  • Glasgow, United Kingdom, G81 4DY
    • Recruiting
    • Golden Jubilee
    • Contact: Keith Oldroyd, Prof
    • Principal Investigator: Keith Oldroyd, Prof
  • London, United Kingdom, SE5 9RS,
    • Recruiting
    • Kings College
    • Contact: Jonathan Hill, Dr
    • Principal Investigator: Jonathan Hill, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients planed for culotte DES stenting

Description

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 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

Collaborators and Investigators

• Sponsor: European Cardiovascular Research Center
• Collaborators: Ceric Sàrl

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: August 25, 2014
• First Submitted That Met QC Criteria: September 3, 2014
• First Posted (Estimate): September 5, 2014

Study Record Updates

• Last Update Posted (Estimate): September 7, 2016
• Last Update Submitted That Met QC Criteria: September 6, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: BSC-02