CELTIC Bifurcation Study

NCT02232815 | Unknown

• 1 other identifier: BSC-02
• Study Type: observational
• Target: 170
• Locations: 2 countries
• Sites: 6

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.

Conditions

Coronary Bifurcations

Outcome Measures

Primary Outcomes (1)

• Composite measure of Adverse events

  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

  9 months

Secondary Outcomes (7)

• Technical success (deployment of stents in both branches with <20% residual stenosis and kissing balloon inflation at end of procedure)

  Day 0, during procedure

• 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

• Evidence of longitudinal stent compression at index implantation

  Day 0, during procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients planed for culotte DES stenting

You may qualify if:

• 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

You may not qualify if:

• Acute myocardial infarction with ongoing ST-elevation
• Cardiogenic shock
• Lesion involves the left main coronary artery
• Lesion involves bypass graft
• 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

Sponsors & Collaborators

• European Cardiovascular Research Center: lead
• Ceric Sàrl: collaborator

Study Sites (6)

St Vincent's Hospital Dublin

Dublin, 4, Ireland

RECRUITING

Belfast Health & Social Care Trust

Belfast, BT8 8BH, United Kingdom

RECRUITING

Bristol Royal Infirmary

Bristol, BS2 8HW, United Kingdom

RECRUITING

Edinburgh Royal Infirmary

Edinburgh, EH16 4SA,, United Kingdom

RECRUITING

Golden Jubilee

Glasgow, G81 4DY, United Kingdom

RECRUITING

Kings College

London, SE5 9RS,, United Kingdom

RECRUITING

Central Study Contacts

David Foley

CONTACT

+35 1 809 3140

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2014
• First Posted: September 5, 2014
• Study Start: December 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2018
• Last Updated: September 7, 2016

Record last verified: 2016-09

Locations

IE (1); GB (5)