Long-term Outcomes of Patients After Coronary Bifurcation Stenting

August 25, 2011 updated by: Scott Kinlay, VA Boston Healthcare System
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

Study Overview

Status

Completed

Conditions

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

160

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • West Roxbury, Massachusetts, United States, 02132
        • VA Boston Healthcare System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patient receiving drug eluting or bare metal coronary stents for coronary bifurcation lesions

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Boston Healthcare System

Investigators

  • Principal Investigator: Scott Kinlay, MBBS, PhD, VA Boston Healthcare System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2001

Primary Completion (ACTUAL)

August 1, 2005

Study Completion (ACTUAL)

August 1, 2005

Study Registration Dates

First Submitted

May 12, 2006

First Submitted That Met QC Criteria

May 12, 2006

First Posted (ESTIMATE)

May 15, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

August 29, 2011

Last Update Submitted That Met QC Criteria

August 25, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VABHS-IRB-1934

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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