Long-term Outcomes of Patients After Coronary Bifurcation Stenting

Coronary Artery Disease Clinical Trial

Official title:

Long-term Outcomes of Patients After Coronary Bifurcation Stenting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00325884
• Other study ID #: VABHS-IRB-1934
• Status: Completed
• Start date: August 2001
• Est. completion date: August 2005

Study information

• Verified date: April 2024
• Source: VA Boston Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: August 2005
• Est. primary completion date: August 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Death
• Infarction
• Myocardial Infarction
• Myocardial Ischemia

Locations

Country	Name	City	State
United States	VA Boston Healthcare System	West Roxbury	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
VA Boston Healthcare System

Country where clinical trial is conducted

United States, 

References & Publications (2)

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/cc — View Citation

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