Coronary BifurcationsNCT02232815
CELTIC Bifurcation Study
An observational study of Coronary Bifurcations, run by European Cardiovascular Research Center at 6 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Bifurcations
- How many people
- 170 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Dec 2014to Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients planed for culotte DES stenting
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
6 sites in 2 countries.
David Foley contact
6 sites in 2 countries
United Kingdom5 sites, 5 recruiting
- Recruiting
Belfast Health & Social Care Trust
Belfast, BT8 8BH
Colm Hanratty, Dr
Colm Hanratty, Dr
- Recruiting
Bristol Royal Infirmary
Bristol, BS2 8HW
Tom Johnson, Dr
Tom Johnson, Dr
- Recruiting
Edinburgh Royal Infirmary
Edinburgh, EH16 4SA,
Nick Cruden
Nick Cruden
- Recruiting
Golden Jubilee
Glasgow, G81 4DY
Keith Oldroyd, Prof
Keith Oldroyd, Prof
- Recruiting
Kings College
London, SE5 9RS,
Jonathan Hill, Dr
Jonathan Hill, Dr
Ireland1 site, 1 recruiting
- Recruiting
St Vincent's Hospital Dublin
Dublin, 4
Niall Mulvahill, Dr
Niall Mulvahill, Dr
About this study
Official title: 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.
- Conditions
- Coronary Bifurcations
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: Day 0, during procedure
Total procedure time
Measured: Day 0, during procedure
Total radiation dose
Measured: Day 0, during procedure
Need to use secondary equipment or manoeuvres to complete the case
extra support guidewires, anchor balloons or mother \& daughter catheter
Measured: Day 0, during procedure
Evidence of longitudinal stent compression at index implantation
Measured: Day 0, during procedure
Evidence of stent fracture at angiographic follow-up
Measured: Day 0, during procedure
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])
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2014 (estimated)
- Study startDec 2014
- Primary completionDec 2016 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary BifurcationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Cardiovascular Research Center
- Sponsor type
- Research network
- Collaborators
- Ceric Sàrl
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02232815
- Sponsor's protocol ID
- BSC-02
- Status last verified
- Sep 2016
- First submitted
- 25 Aug 2014
- Last updated
- 7 Sep 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02232815
- Acronym / sponsor ID
- BSC-02
- Conditions
- Coronary Bifurcations
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- European Cardiovascular Research CenterResearch network
- Collaborators
- Ceric Sàrl
- Study start
- Dec 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 5 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients planed for culotte DES stenting
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
7 secondary outcomes
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
Total procedure time
Time frame: Day 0, during procedure
Total radiation dose
Time frame: Day 0, during procedure
Need to use secondary equipment or manoeuvres to complete the case
Time frame: Day 0, during procedure
Evidence of longitudinal stent compression at index implantation
Time frame: Day 0, during procedure
Evidence of stent fracture at angiographic follow-up
Time frame: Day 0, during procedure
Composite measure of Adverse events
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Foley contact
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Bifurcations, run by European Cardiovascular Research Center at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United Kingdom, Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David Foley (+35 1 809 3140), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite measure of Adverse events (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2016.