Long-term Outcomes of Patients After Coronary Bifurcation Stenting
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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
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Retrospective |
| Official Title: | Long-term Outcomes of Patients After Coronary Bifurcation Stenting |
| 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) |
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 |
Patient receiving drug eluting or bare metal coronary stents for coronary bifurcation lesions
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| United States, Massachusetts | |
| VA Boston Healthcare System | |
| West Roxbury, Massachusetts, United States, 02132 | |
| 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 June 18, 2013