NCT00325884

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2001

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2001

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 12, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 15, 2006

Completed
Last Updated

April 23, 2024

Status Verified

April 1, 2024

Enrollment Period

4 years

First QC Date

May 12, 2006

Last Update Submit

April 22, 2024

Conditions

Coronary Artery DiseaseDeathMyocardial Infarction

Keywords

coronary artery diseasebifurcation lesionspercutaneous interventionsstentingoutcomesdeathmyocardial infarction

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Boston Healthcare System

West Roxbury, Massachusetts, 02132, United States

Location

Related Publications (2)

  • 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

    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.

    PMID: 20824754RESULT

MeSH Terms

Conditions

Coronary Artery DiseaseDeathMyocardial Infarction

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsInfarctionIschemiaNecrosis

Study Officials

  • Scott Kinlay, MBBS, PhD

    VA Boston Healthcare System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Cardiac Catheterization Laboratory

Study Record Dates

First Submitted

May 12, 2006

First Posted

May 15, 2006

Study Start

August 1, 2001

Primary Completion

August 1, 2005

Study Completion

August 1, 2005

Last Updated

April 23, 2024

Record last verified: 2024-04

Locations

US(1)