Status:
UNKNOWN
CELTIC Bifurcation Study
Lead Sponsor:
European Cardiovascular Research Center
Collaborating Sponsors:
Ceric Sàrl
Conditions:
Coronary Bifurcations
Eligibility:
All Genders
18+ years
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 pla...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2018
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT02232815
Start Date
December 1 2014
End Date
December 1 2018
Last Update
September 7 2016
Active Locations (6)
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1
St Vincent's Hospital Dublin
Dublin, Ireland, 4
2
Belfast Health & Social Care Trust
Belfast, United Kingdom, BT8 8BH
3
Bristol Royal Infirmary
Bristol, United Kingdom, BS2 8HW
4
Edinburgh Royal Infirmary
Edinburgh, United Kingdom, EH16 4SA,