NCT00351260

Brief Summary

The study aims to assess whether a SIMPLE or a COMPLEX strategy is best for the treatment of coronary bifurcation stenoses.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 2005

Typical duration 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

January 1, 2005

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 11, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 12, 2006

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

April 16, 2008

Status Verified

March 1, 2008

Enrollment Period

2.9 years

First QC Date

July 11, 2006

Last Update Submit

April 15, 2008

Conditions

Ischaemic Heart DiseasesStenosisAngina

Keywords

BifurcationCoronaryStenosisStentdrug elution

Outcome Measures

Primary Outcomes (3)

  • Death

  • Myocardial infarction

  • Target vessel revascularisation

Secondary Outcomes (2)

  • Repeat angiography

  • Stent thrombosis

Interventions

Coronary AngioplastyPROCEDURE

Eligibility Criteria

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

You may qualify if:

  • Coronary Bifurcation Lesion requiring treatment

You may not qualify if:

  • Cardiogenic Shock
  • Acute MI
  • Additional type C lesion for Rx platelets \<50
  • LVEF \<20%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Sussex County Hospital

Brighton, BN2 5BE, United Kingdom

Location

Related Publications (3)

  • Behan MW, Holm NR, de Belder AJ, Cockburn J, Erglis A, Curzen NP, Niemela M, Oldroyd KG, Kervinen K, Kumsars I, Gunnes P, Stables RH, Maeng M, Ravkilde J, Jensen JS, Christiansen EH, Cooter N, Steigen TK, Vikman S, Thuesen L, Lassen JF, Hildick-Smith D. Coronary bifurcation lesions treated with simple or complex stenting: 5-year survival from patient-level pooled analysis of the Nordic Bifurcation Study and the British Bifurcation Coronary Study. Eur Heart J. 2016 Jun 21;37(24):1923-8. doi: 10.1093/eurheartj/ehw170. Epub 2016 May 8.

    PMID: 27161619DERIVED

  • Behan MW, Holm NR, Curzen NP, Erglis A, Stables RH, de Belder AJ, Niemela M, Cooter N, Chew DP, Steigen TK, Oldroyd KG, Jensen JS, Lassen JF, Thuesen L, Hildick-Smith D. Simple or complex stenting for bifurcation coronary lesions: a patient-level pooled-analysis of the Nordic Bifurcation Study and the British Bifurcation Coronary Study. Circ Cardiovasc Interv. 2011 Feb 1;4(1):57-64. doi: 10.1161/CIRCINTERVENTIONS.110.958512. Epub 2011 Jan 4.

    PMID: 21205942DERIVED

  • 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 Mar 16;121(10):1235-43. doi: 10.1161/CIRCULATIONAHA.109.888297. Epub 2010 Mar 1.

    PMID: 20194880DERIVED

MeSH Terms

Conditions

Coronary Artery DiseaseConstriction, PathologicAngina Pectoris

Interventions

Angioplasty, Balloon

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsChest PainPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AngioplastyCatheterizationTherapeuticsEndovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical ProceduresInvestigative Techniques

Study Officials

  • David J.R, Hildick-Smith, MD

    Royal Sussex County Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 11, 2006

First Posted

July 12, 2006

Study Start

January 1, 2005

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

April 16, 2008

Record last verified: 2008-03

Locations

GB(1)