Long-term Outcomes of Patients After Coronary Bifurcation Stenting

Completed

• Conditions: Coronary Artery Disease; Death; Myocardial Infarction

• Registration Number: NCT00325884
• Lead Sponsor: VA Boston Healthcare System

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

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

Study Timeline

• Study Start: 2001-08
• Primary Completion: 2005-08
• Study Completion: 2005-08
• Study First Submitted: 2006-05-12
• Study First Submitted QC: 2006-05-12
• Study First Posted: 2006-05-15
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-22
• Last Update Posted: 2024-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

VA Boston Healthcare System; 🇺🇸 West Roxbury, Massachusetts, United States