CELTIC Bifurcation Study

September 6, 2016 updated by: European Cardiovascular Research Center

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
170

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: David Foley
  • Phone Number: +35 1 809 3140

Study Locations

  • Ireland
      • Dublin, Ireland, 4
        • Recruiting
        • St Vincent's Hospital Dublin
        • Contact:
          • Niall Mulvahill, Dr
        • Principal Investigator:
          • Niall Mulvahill, Dr
  • United Kingdom
      • Belfast, United Kingdom, BT8 8BH
        • Recruiting
        • Belfast Health & Social Care Trust
        • Contact:
          • Colm Hanratty, Dr
        • Principal Investigator:
          • Colm Hanratty, Dr
      • Bristol, United Kingdom, BS2 8HW
        • Recruiting
        • Bristol Royal Infirmary
        • Contact:
          • Tom Johnson, Dr
        • Principal Investigator:
          • Tom Johnson, Dr
      • Edinburgh, United Kingdom, EH16 4SA,
        • Recruiting
        • Edinburgh Royal Infirmary
        • Contact:
          • Nick Cruden
        • Principal Investigator:
          • Nick Cruden
      • Glasgow, United Kingdom, G81 4DY
        • Recruiting
        • Golden Jubilee
        • Contact:
          • Keith Oldroyd, Prof
        • Principal Investigator:
          • Keith Oldroyd, Prof
      • London, United Kingdom, SE5 9RS,
        • Recruiting
        • Kings College
        • Contact:
          • Jonathan Hill, Dr
        • Principal Investigator:
          • Jonathan Hill, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients planed for culotte DES stenting

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Composite measure of Adverse events
Time Frame: 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
9 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Technical success (deployment of stents in both branches with <20% residual stenosis and kissing balloon inflation at end of procedure)
Time Frame: Day 0, during procedure
Day 0, during procedure
Total procedure time
Time Frame: Day 0, during procedure
Day 0, during procedure
Total radiation dose
Time Frame: Day 0, during procedure
Day 0, during procedure
Need to use secondary equipment or manoeuvres to complete the case
Time Frame: Day 0, during procedure
extra support guidewires, anchor balloons or mother & daughter catheter
Day 0, during procedure
Evidence of longitudinal stent compression at index implantation
Time Frame: Day 0, during procedure
Day 0, during procedure
Evidence of stent fracture at angiographic follow-up
Time Frame: Day 0, during procedure
Day 0, during procedure
Composite measure of Adverse events
Time Frame: 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])
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
European Cardiovascular Research Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ceric Sàrl

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2014

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2016

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 25, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 3, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 5, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 7, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 6, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BSC-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings