Condition category
Circulatory System
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
17/03/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr David Hildick-Smith

ORCID ID

Contact details

Brighton & Sussex University Hospitals NHS Trust (RSCH)
Royal Sussex County Hospital
Eastern Road
Brighton
BN2 5BE
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00351260

Protocol/serial number

N0051154079

Study information

Scientific title

Acronym

Study hypothesis

When treating a bifurcation coronary artery lesion is it best to treat the main vessel only, or to stent both the main vessel and the side branch?

Please note that as of 17/03/10 this trial has been updated to include exclusion criteria and secondary outcomes. All updates can be found in the relevant field with the above update date.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Coronary disease

Intervention

Randomised trial comparing stents either in a simple strategy (provisional T stenting) or a complex strategy (total lesion coverage) and to compare outcomes at nine months

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The primary end point will be a composite of death, myocardial infarction or target vessel failure at nine months

Secondary outcome measures

Added 17/03/10:
1. Repeat angiography
2. Stent thrombosis

Overall trial start date

01/10/2004

Overall trial end date

30/09/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Men and women over 18 presenting with coronary bifurcation lesions > 2.5mm main vessel and 2.25mm side branch.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

500

Participant exclusion criteria

Added 17/03/10:
1. Cardiogenic Shock
2. Acute Myocardial Infarction (MI)
3. Additional type C lesion for Rx platelets <50
4. Left Ventricular Ejection Fraction LVEF <20%

Recruitment start date

01/10/2004

Recruitment end date

30/09/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Brighton & Sussex University Hospitals NHS Trust (RSCH)
Brighton
BN2 5BE
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2006 Update - Department of Health

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Brighton and Sussex University Hospitals NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NHS R&D Support Funding

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20194880

Publication citations

  1. Results

    Hildick-Smith D, de Belder AJ, Cooter N, Curzen NP, Clayton TC, Oldroyd KG, Bennett L, Holmberg S, Cotton JM, Glennon PE, Thomas MR, Maccarthy PA, Baumbach A, Mulvihill NT, Henderson RA, Redwood SR, Starkey IR, Stables RH, Randomized trial of simple versus complex drug-eluting stenting for bifurcation lesions: the British Bifurcation Coronary Study: old, new, and evolving strategies., Circulation, 2010, 121, 10, 1235-1243, doi: 10.1161/CIRCULATIONAHA.109.888297.

Additional files

Editorial Notes