NCT01560455

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P25-P50 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 16, 2011

Completed
6 months until next milestone

First Posted

Study publicly available on registry

March 22, 2012

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Last Updated

March 14, 2016

Status Verified

March 1, 2016

Enrollment Period

3.3 years

First QC Date

September 16, 2011

Last Update Submit

March 11, 2016

Conditions

Coronary Disease

Keywords

stentbifurcationcoronary

Outcome Measures

Primary Outcomes (1)

  • Composite primary endpoint (Death, MI, TVR)

    Death Myocardial infarction Target Vessel Revascularisation

    12 months

Secondary Outcomes (1)

  • Stent thrombosis

    12 months

Study Arms (2)

single stent

ACTIVE COMPARATOR

single stent

Device: single stent

dual stent

ACTIVE COMPARATOR

dual stent (culotte)

Device: two stent

Interventions

single stentDEVICE

single stent

Also known as: Terumo Nobori stent
single stent
two stentDEVICE

culotte

Also known as: Terumo Nobori stent
dual stent

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • "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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sussex Cardiac Centre

Brighton, East Sussex, BN2 1DE, United Kingdom

Location

Related Publications (2)

  • 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.

    PMID: 37946522DERIVED

  • Hildick-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.

    PMID: 27578839DERIVED

MeSH Terms

Conditions

Coronary Disease

Interventions

Stents

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Prostheses and ImplantsEquipment and Supplies

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Cardiologist

Study Record Dates

First Submitted

September 16, 2011

First Posted

March 22, 2012

Study Start

May 1, 2011

Primary Completion

September 1, 2014

Last Updated

March 14, 2016

Record last verified: 2016-03

Locations

GB(1)