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Long-term Outcomes of Patients After Coronary Bifurcation Stenting

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00325884
First Posted: May 15, 2006
Last Update Posted: August 29, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Scott Kinlay, VA Boston Healthcare System
  Purpose
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

Condition Phase
Coronary Artery Disease Death Myocardial Infarction Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Long-term Outcomes of Patients After Coronary Bifurcation Stenting

Further study details as provided by Scott Kinlay, VA Boston Healthcare System:

Enrollment: 160
Study Start Date: August 2001
Study Completion Date: August 2005
Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient receiving drug eluting or bare metal coronary stents for coronary bifurcation lesions
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00325884


Locations
United States, Massachusetts
VA Boston Healthcare System
West Roxbury, Massachusetts, United States, 02132
Sponsors and Collaborators
VA Boston Healthcare System
Investigators
Principal Investigator: Scott Kinlay, MBBS, PhD VA Boston Healthcare System
  More Information

Publications:
Zamani P, Kinlay S. Relationship of side-branch intervention and drug-eluting stents to long-term outcomes after coronary bifurcation stenting. J Am Coll Cardiol 2008; 51(suppl B): B50-B51

Responsible Party: Scott Kinlay, Director, Cardiac Catheterization Laboratory, VA Boston Healthcare System
ClinicalTrials.gov Identifier: NCT00325884     History of Changes
Other Study ID Numbers: VABHS-IRB-1934
First Submitted: May 12, 2006
First Posted: May 15, 2006
Last Update Posted: August 29, 2011
Last Verified: August 2011

Keywords provided by Scott Kinlay, VA Boston Healthcare System:
coronary artery disease
bifurcation lesions
percutaneous interventions
stenting
outcomes
death
myocardial infarction

Additional relevant MeSH terms:
Infarction
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases