Coronary DiseasePhase 3EBC TWONCT01560455
European Bifurcation Club Trial - Two-stent Versus One-stent Technique for Large Bifurcation Lesions
A Phase 3 study testing single stent and two stent in people with Coronary Disease, run by Royal Sussex County Hospital at 1 site in United Kingdom.
Trial summary
This study will examine use of two-stent versus one-stent techniques for patients with large calibre bifurcation lesions including significant side branch disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Disease
- What is being tested?
- single stent and two stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2011to Sep 2014
- Phase
- Phase 3
- 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
Who may be able to join
- "True" coronary bifurcation lesion (i.e. >50% lesion in both main vessel and side branch) requiring revascularisation
- Main vessel ≥ 2.5mm diameter (visual inspection)
- Side branch ≥ 2.5mm diameter (visual inspection)
- Side branch ostial lesion ≥5mm length
- Patient ≥18 years old
- Females of childbearing potential: -ve pregnancy test
Who cannot join
- Acute ST elevation myocardial infarction
- Cardiogenic shock
- Left main stem lesion of haemodynamic significance
- Chronic total occlusion of either vessel
- Additional Type C lesions requiring PCI
- Either bifurcation vessel not suitable for stenting
Show all 12Show fewer
- Platelet count ≤50 x 109/mm3
- Left ventricular ejection fraction ≤20%
- Patient life expectancy less than 12 months
- Known allergies to aspirin, clopidogrel, heparin, stainless steel, intravenous contrast (severe), or stent drug elutant
- Participation in another investigational drug or device study
- Patient unable to give informed consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sussex Cardiac Centre
Brighton, East Sussex, BN2 1DE
About this study
Official title: The European Bifurcation Coronary Study; A Randomised Comparison Of Provisional T-Stenting Versus A Systematic Two Stent Strategy In Large Calibre True Bifurcations
This study will examine use of two-stent versus one-stent techniques for patients with large calibre bifurcation lesions including significant side branch disease.
Read the detailed description
Treatment of bifurcation coronary lesions remains a difficult area, in which best practice is yet to be established. Prior to the era of drug-eluting stents, the limited data which existed suggested that a strategy of stenting the main vessel, with balloon angioplasty alone of the side-branch if required was superior to stenting both vessels.
Randomised trials of "all-comer" bifurcation lesions have now established that there is no advantage to systematic dual drug-eluting stent strategies. However, these trials included patients with no disease in the side branch, and small side branch vessels.
Expert consensus suggests that "large" bifurcations with significant ostial side branch disease still merit a systematic total lesion coverage stent technique. This trial therefore is designed to assess the hypothesis that large true bifurcations with significant side branch ostial disease are more successfully treated with a systematic culotte technique than with the provisional T approach.
- Conditions
- Coronary Disease
- Being tested
- single stent, two stent
- Keywords
- stent, bifurcation, coronary
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
single stentDevice
Also called Terumo Nobori stent
single stent
two stentDevice
Also called Terumo Nobori stent
culotte
| Study group | Role | What they receive |
|---|---|---|
| single stent | Active comparator | single stent Receives: Device: single stent |
| dual stent | Active comparator | dual stent (culotte) Receives: Device: two stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite primary endpoint (Death, MI, TVR)
Death Myocardial infarction Target Vessel Revascularisation
Measured: 12 months
Secondary outcomes (1)
Stent thrombosis
Stent thrombosis
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2012 (estimated)
- Study startMay 2011
- Primary completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary DiseaseStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Sussex County Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Terumo Corporation
- Responsible party
- Principal investigator, David Hildick-Smith, Royal Sussex County Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01560455
- Sponsor's protocol ID
- EBC TWO
- Acronym
- EBC TWO
- Status last verified
- Mar 2016
- First submitted
- 16 Sep 2011
- Last updated
- 14 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Arunothayaraj S, Behan MW, Lefevre T, Lassen JF, Chieffo A, Stankovic G, Burzotta F, Pan M, Ferenc M, Hovasse T, Spence MS, Brunel P, Cotton JM, Cockburn J, Carrie D, Baumbach A, Maeng M, Louvard Y, Hildick-Smith D. Stepwise provisional versus systematic culotte for stenting of true coronary bifurcation lesions: five-year follow-up of the multicentre randomised EBC TWO Trial. EuroIntervention. 2023 May 16;19(4):e297-304. doi: 10.4244/EIJ-D-23-00211. Online ahead of print.
PubMed 37946522Hildick-Smith D, Behan MW, Lassen JF, Chieffo A, Lefevre T, Stankovic G, Burzotta F, Pan M, Ferenc M, Bennett L, Hovasse T, Spence MJ, Oldroyd K, Brunel P, Carrie D, Baumbach A, Maeng M, Skipper N, Louvard Y. The EBC TWO Study (European Bifurcation Coronary TWO): A Randomized Comparison of Provisional T-Stenting Versus a Systematic 2 Stent Culotte Strategy in Large Caliber True Bifurcations. Circ Cardiovasc Interv. 2016 Sep;9(9):e003643. doi: 10.1161/CIRCINTERVENTIONS.115.003643.
PubMed 27578839
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The European Bifurcation Coronary Study; A Randomised Comparison Of Provisional T-Stenting Versus A Systematic Two Stent Strategy In Large Calibre True Bifurcations
- ClinicalTrials.gov ID
- NCT01560455
- Acronym / sponsor ID
- EBC TWO / EBC TWO
- Conditions
- Coronary Disease
- Keywords
- stent, bifurcation, coronary
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Royal Sussex County HospitalUniversity, hospital or other
- Collaborators
- Terumo Corporation
- Study start
- May 2011
- Primary completion
- Sep 2014 (actual)
- First posted
- 22 Mar 2012 (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 use of two-stent versus one-stent techniques for patients with large calibre bifurcation lesions including significant side branch disease.
Detailed description
Treatment of bifurcation coronary lesions remains a difficult area, in which best practice is yet to be established. Prior to the era of drug-eluting stents, the limited data which existed suggested that a strategy of stenting the main vessel, with balloon angioplasty alone of the side-branch if required was superior to stenting both vessels.
Randomised trials of "all-comer" bifurcation lesions have now established that there is no advantage to systematic dual drug-eluting stent strategies. However, these trials included patients with no disease in the side branch, and small side branch vessels.
Expert consensus suggests that "large" bifurcations with significant ostial side branch disease still merit a systematic total lesion coverage stent technique. This trial therefore is designed to assess the hypothesis that large true bifurcations with significant side branch ostial disease are more successfully treated with a systematic culotte technique than with the provisional T approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| single stent | Active comparator | Device: single stentsingle stent |
| dual stent | Active comparator | Device: two stentdual stent (culotte) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- "True" coronary bifurcation lesion (i.e. >50% lesion in both main vessel and side branch) requiring revascularisation
- Main vessel ≥ 2.5mm diameter (visual inspection)
- Side branch ≥ 2.5mm diameter (visual inspection)
- Side branch ostial lesion ≥5mm length
- Patient ≥18 years old
Key exclusion criteria (12 listed)
- Acute ST elevation myocardial infarction
- Cardiogenic shock
- Left main stem lesion of haemodynamic significance
- Chronic total occlusion of either vessel
- Additional Type C lesions requiring PCI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| single stentAlso: Terumo Nobori stentsingle stent | Device | single stent |
| two stentAlso: Terumo Nobori stentculotte | Device | dual stent |
Primary outcome
Composite primary endpoint (Death, MI, TVR)
Time frame: 12 months
Death Myocardial infarction Target Vessel Revascularisation
1 secondary outcome
Stent thrombosis
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2016.
- Derived from this study: PubMed 37946522Arunothayaraj S, Behan MW, Lefevre T, Lassen JF, Chieffo A, Stankovic G, Burzotta F, Pan M, Ferenc M, Hovasse T, Spence MS, Brunel P, Cotton JM, Cockburn J, Carrie D, Baumbach A, Maeng M, Louvard Y, Hildick-Smith D. Stepwise provisional versus systematic culotte for stenting of true coronary bifurcation lesions: five-year follow-up of the multicentre randomised EBC TWO Trial. EuroIntervention. 2023 May 16;19(4):e297-304. doi: 10.4244/EIJ-D-23-00211. Online ahead of print.
- Derived from this study: PubMed 27578839Hildick-Smith D, Behan MW, Lassen JF, Chieffo A, Lefevre T, Stankovic G, Burzotta F, Pan M, Ferenc M, Bennett L, Hovasse T, Spence MJ, Oldroyd K, Brunel P, Carrie D, Baumbach A, Maeng M, Skipper N, Louvard Y. The EBC TWO Study (European Bifurcation Coronary TWO): A Randomized Comparison of Provisional T-Stenting Versus a Systematic 2 Stent Culotte Strategy in Large Caliber True Bifurcations. Circ Cardiovasc Interv. 2016 Sep;9(9):e003643. doi: 10.1161/CIRCINTERVENTIONS.115.003643.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing single stent and two stent in people with Coronary Disease, run by Royal Sussex County Hospital at 1 site in United Kingdom.
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 12 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: finished, as of the sponsor's last update on 14 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite primary endpoint (Death, MI, TVR) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01560455, which also lists 2 linked publications.
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 14 Mar 2016.