Long-term Outcomes of Patients After Coronary Bifurcation Stenting

NCT ID: NCT00325884

Last Updated: 2024-04-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2001-08-31

Study Completion Date

2005-08-31

Brief Summary

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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

Detailed Description

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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

Conditions

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Coronary Artery Disease Death Myocardial Infarction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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VA Boston Healthcare System

FED

Sponsor Role lead

Responsible Party

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Scott Kinlay

Director, Cardiac Catheterization Laboratory

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Scott Kinlay, MBBS, PhD

Role: PRINCIPAL_INVESTIGATOR

VA Boston Healthcare System

Locations

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VA Boston Healthcare System

West Roxbury, Massachusetts, United States

Site Status

Countries

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United States

References

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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

Reference Type RESULT

Zamani P, Kinlay S. Long-term risk of clinical events from stenting side branches of coronary bifurcation lesions with drug-eluting and bare-metal stents: an observational meta-analysis. Catheter Cardiovasc Interv. 2011 Feb 1;77(2):202-12. doi: 10.1002/ccd.22750.

Reference Type RESULT
PMID: 20824754 (View on PubMed)

Other Identifiers

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VABHS-IRB-1934

Identifier Type: -

Identifier Source: org_study_id

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