NCT02232815|Unknown
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
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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
Sponsor study identifier
observational
170
2 countries
6
Study Start
December 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 25, 2014
Actual (reported)September 5, 2014
Actual (reported)December 2014
Date type not reportedThis date has not been verified as actual or estimated.
December 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
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
Day 0, during procedure
Evidence of longitudinal stent compression at index implantation
Day 0, during procedure
Patients planed for culotte DES stenting
St Vincent's Hospital Dublin
Dublin, 4, Ireland
Belfast Health & Social Care Trust
Belfast, BT8 8BH, United Kingdom
Bristol Royal Infirmary
First Submitted
August 25, 2014
First Posted
September 5, 2014
Study Start
December 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2016
Estimated (date passed)Contact the study team to confirm eligibility.
Bristol, BS2 8HW, United Kingdom
Edinburgh Royal Infirmary
Edinburgh, EH16 4SA,, United Kingdom
Golden Jubilee
Glasgow, G81 4DY, United Kingdom
Kings College
London, SE5 9RS,, United Kingdom
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
September 7, 2016
Record last verified: 2016-09
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Source: ClinicalTrials.gov.
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