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Completed

NCT Number: NCT00351260

BBC ONE - British Bifurcation Coronary Study

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

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Key information

Conditions

Ischaemic Heart Diseases Angina Angina Pectoris Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Chest Pain Constriction, Pathologic Coronary Artery Disease Coronary Disease Heart Diseases Myocardial Ischemia Neurologic Manifestations Pain Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms Stenosis Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Royal Sussex County Hospital

Brighton, BN2 5BE, United Kingdom

About this study

500 patients will be randomised to either a SIMPLE strategy (provisional T stenting) or a COMPLEX strategy (crush or culotte stenting) with clinical follow-up at 9 months.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

>18 years

  • Coronary Bifurcation Lesion requiring treatment

Exclusion criteria

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

Treatment and study plan

Coronary angioplasty

Procedure

Primary outcomes

  1. Death

  2. Myocardial infarction

  3. Target vessel revascularisation

Secondary outcomes

  1. Repeat angiography

  2. Stent thrombosis

Sponsors and collaborators

Lead sponsor

Royal Sussex County Hospital

Other

Registry information

Official study title

British Bifurcation Coronary Study - Old, New and Evolving Strategies.

Acronym: BBC ONE

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Jul 12, 2006
Registry last updated
Apr 16, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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