CELTIC Bifurcation Study

Coronary Bifurcations Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02232815
• Other study ID #: BSC-02
• Status: Recruiting
• Phase: N/A
• First received: August 25, 2014
• Last updated: September 6, 2016
• Start date: December 2014
• Est. completion date: December 2018

Study information

• Verified date: September 2016
• Source: European Cardiovascular Research Center
• Contact: David Foley
• Phone: +35 1 809 3140
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethic Commitee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 170
• Est. completion date: December 2018
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Bifurcations

Locations

Country	Name	City	State
Ireland	St Vincent's Hospital Dublin	Dublin
United Kingdom	Belfast Health & Social Care Trust	Belfast
United Kingdom	Bristol Royal In?rmary	Bristol
United Kingdom	Edinburgh Royal In?rmary	Edinburgh
United Kingdom	Golden Jubilee	Glasgow
United Kingdom	Kings College	London

Sponsors (2)

Lead Sponsor	Collaborator
European Cardiovascular Research Center	Ceric Sàrl

Countries where clinical trial is conducted

Ireland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Technical success (deployment of stents in both branches with <20% residual stenosis and kissing balloon inflation at end of procedure)		Day 0, during procedure	No
Secondary	Total procedure time		Day 0, during procedure	No
Secondary	Total radiation dose		Day 0, during procedure	No
Secondary	Need to use secondary equipment or manoeuvres to complete the case	extra support guidewires, anchor balloons or mother & daughter catheter	Day 0, during procedure	No
Secondary	Evidence of longitudinal stent compression at index implantation		Day 0, during procedure	No
Secondary	Evidence of stent fracture at angiographic follow-up		Day 0, during procedure	No
Secondary	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	Yes