Long-term Outcomes of Patients After Coronary Bifurcation Stenting

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Scott Kinlay, VA Boston Healthcare System
ClinicalTrials.gov Identifier:
NCT00325884
First received: May 12, 2006
Last updated: August 25, 2011
Last verified: August 2011
  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

Resource links provided by NLM:


Further study details as provided by 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

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
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
Study First Received: May 12, 2006
Last Updated: August 25, 2011
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on July 31, 2014