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OpenTrials
Completed

NCT Number: NCT00325884

Long-term Outcomes of Patients After Coronary Bifurcation Stenting

The purpose of this study is to assess the long-term clinical outcomes after stenting bifurcation coronary artery lesions, and to determine whether simple or more complex techniques are associated with a better clinical outcome. We will also assess the risk factors associated with poorer clinical outcomes

Completed

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

VA Boston Healthcare System

West Roxbury, Massachusetts, 02132, United States

About this study

Coronary artery disease affecting the branch points of coronary arteries (bifurcation lesions) has a higher rate of restenosis after angioplasty than disease in regions not involving branch points. Post-procedural angiographic outcomes and in-hospital outcomes have been documented for a variety of techniques, but none have examined the long-term clinical outcomes.

Long-term clinical outcomes are important from the patients point of view and also determine the use of resources. Knowledge of the long-term outcomes from the various techniques used to treat bifurcation lesions would be important in determining guidelines for the treatment of bifurcation lesions. If simple techniques offer similar or better outcomes than more complex strategies, then this would justify simpler techniques such as main vessel stenting that would use less resources, expose the patient to less radiation, and contrast related to prolonged angioplasty procedures.

Comparisons: We will compare the long-term outcomes of simple versus complex stent techniques, and determine other risk factors for long-term outcome

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • de novo coronary artery lesion in a main branch with at least a 50% stenosis
  • lesions involve the ostium of a side branch artery
  • main branch and side branch with reference diameters of at least 2mm
  • at least one stent used to treat the lesion

Exclusion criteria

  • restenosis lesions
  • reference side branch artery less than 2mm diameter
  • multiple bifurcation lesions

Sponsors and collaborators

Lead sponsor

VA Boston Healthcare System

Fed

Registry information

Important dates

Study start
2001
Primary completion
2005
Study completion
2005
First posted
May 15, 2006
Registry last updated
Apr 23, 2024

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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