CELTIC Bifurcation Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

170 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-12-31

Study Completion Date

2018-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Coronary Bifurcations

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No