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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 September 2016 |
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Main ID: |
NCT02232815 |
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Date of registration:
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25/08/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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CELTIC Bifurcation Study
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Scientific title:
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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 |
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Date of first enrolment:
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December 2014 |
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Target sample size:
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170 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02232815 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Phase:
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N/A
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Countries of recruitment
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Ireland
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United Kingdom
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Contacts
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Name:
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David Foley |
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Address:
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Telephone:
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+35 1 809 3140 |
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Coronary Bifurcations
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Primary Outcome(s)
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Composite measure of Adverse events
[Time Frame: 9 months]
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Secondary Outcome(s)
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Composite measure of Adverse events
[Time Frame: 24 months]
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Total radiation dose
[Time Frame: Day 0, during procedure]
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Evidence of longitudinal stent compression at index implantation
[Time Frame: Day 0, during procedure]
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Need to use secondary equipment or manoeuvres to complete the case
[Time Frame: Day 0, during procedure]
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Total procedure time
[Time Frame: Day 0, during procedure]
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Evidence of stent fracture at angiographic follow-up
[Time Frame: Day 0, during procedure]
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Technical success (deployment of stents in both branches with <20% residual stenosis and kissing balloon inflation at end of procedure)
[Time Frame: Day 0, during procedure]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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