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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02232815

Enrollment

170

Registered

2014-09-05

Start date

2014-12-31

Completion date

2018-12-31

Last updated

2016-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Bifurcations

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Composite measure of Adverse events	9 months	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

Secondary

Measure	Time frame	Description
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	extra support guidewires, anchor balloons or mother & daughter catheter
Technical success (deployment of stents in both branches with <20% residual stenosis and kissing balloon inflation at end of procedure)	Day 0, during procedure	—
Evidence of stent fracture at angiographic follow-up	Day 0, during procedure	—
Composite measure of Adverse events	24 months	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 \[14\])
Evidence of longitudinal stent compression at index implantation	Day 0, during procedure	—

Countries

Ireland, United Kingdom

Contacts

Primary ContactDavid Foley

+35 1 809 3140

Outcome results