European Bifurcation Club Trial - Two-stent Versus One-st... | NCT01560455

Studies
European Bifurcation Club Trial - Two-stent Versus One-stent Technique for Large Bifurcation Lesions

NCT01560455

Sponsor

Royal Sussex County Hospital

Status

Completed

Last Update Posted

Mar 14, 2016Estimated

Enrollment

200Estimated

Phase

Phase 3

Conditions

Coronary Disease

Interventions

single stent
two stent

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2011

Primary Completion Date

Sep 2014Actual

Completion Date

Not provided

First Submitted Date

Sep 16, 2011

First Submission Date that Met QC Criteria

Mar 21, 2012

First Posted Date

Mar 22, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 11, 2016

Last Update Posted Date

Mar 14, 2016Estimated

Name	Class
Terumo Corporation	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
single stent	Active Comparator	single stent	Device: single stent
dual stent	Active Comparator	dual stent (culotte)	Device: two stent

Interventions

Name	Type	Description	Arm Group Labels	Other Names
single stent	Device	single stent	single stent	Terumo Nobori stent

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Composite primary endpoint (Death, MI, TVR)	Death Myocardial infarction Target Vessel Revascularisation	12 months

Secondary Outcomes

Measure	Description	Time Frame
Stent thrombosis	Stent thrombosis	12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

"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

Exclusion Criteria:

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
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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Sussex Cardiac Centre		Brighton	East Sussex	BN2 1DE	United Kingdom

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37946522	Derived	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.
27578839

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

ID	Term
D019736	Prostheses and Implants
D004864	Equipment and Supplies