Clinical trial NCT02232815: CELTIC Bifurcation Study
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Bifurcations
Lead sponsor: European Cardiovascular Research Center
Sponsor class: NETWORK
Collaborators: name: Ceric Sàrl
First posted: 2014-09-05
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients planed for culotte DES stenting

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.


Eligibility criteria: 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

Primary outcomes:
measure: Composite measure of Adverse events
timeFrame: 9 months
Secondary outcomes:
measure: Technical success (deployment of stents in both branches with <20% residual stenosis and kissing balloon inflation at end of procedure)
timeFrame: Day 0, during procedure
measure: Total procedure time
timeFrame: Day 0, during procedure
measure: Total radiation dose
timeFrame: Day 0, during procedure
measure: Need to use secondary equipment or manoeuvres to complete the case
timeFrame: Day 0, during procedure
measure: Evidence of longitudinal stent compression at index implantation
timeFrame: Day 0, during procedure
measure: Evidence of stent fracture at angiographic follow-up
timeFrame: Day 0, during procedure
measure: Composite measure of Adverse events
timeFrame: 24 months
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: St Vincent's Hospital Dublin
city: Belfast
country: United Kingdom
facility: Belfast Health & Social Care Trust
city: Bristol
country: United Kingdom
facility: Bristol Royal Inﬁrmary
city: Edinburgh
country: United Kingdom
facility: Edinburgh Royal Inﬁrmary
city: Glasgow
country: United Kingdom
facility: Golden Jubilee
city: London
country: United Kingdom
facility: Kings College
Study officials:
References: