Coronary Artery DiseaseNCT00325884
Long-term Outcomes of Patients After Coronary Bifurcation Stenting
An observational study of Coronary Artery Disease and Death, run by VA Boston Healthcare System at 1 site in United States.
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 Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Coronary Artery Disease, Death, Myocardial Infarction
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2001to Aug 2005
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient receiving drug eluting or bare metal coronary stents for coronary bifurcation lesions
Who may be able to join
- 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
Who cannot join
- restenosis lesions
- reference side branch artery less than 2mm diameter
- multiple bifurcation lesions
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Boston Healthcare System
West Roxbury, Massachusetts, 02132
About this study
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
Read the 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
- Conditions
- Coronary Artery Disease, Death, Myocardial Infarction
- Keywords
- coronary artery disease, bifurcation lesions, percutaneous interventions, stenting, outcomes, death, myocardial infarction
- Medical subject headings
- Coronary Artery Disease, Death, Myocardial Infarction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2006 (estimated)
- Study startAug 2001
- Primary completionAug 2005
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Boston Healthcare System
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Scott Kinlay, VA Boston Healthcare System
- Investigators
- Scott Kinlay, MBBS, PhD, Principal investigator, VA Boston Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00325884
- Sponsor's protocol ID
- VABHS-IRB-1934
- Status last verified
- Apr 2024
- First submitted
- 12 May 2006
- Last updated
- 23 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
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
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.
PubMed 20824754
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Outcomes of Patients After Coronary Bifurcation Stenting
- ClinicalTrials.gov ID
- NCT00325884
- Acronym / sponsor ID
- VABHS-IRB-1934
- Conditions
- Coronary Artery Disease, Death, Myocardial Infarction
- Keywords
- coronary artery disease, bifurcation lesions, percutaneous interventions, stenting, outcomes, death, myocardial infarction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- VA Boston Healthcare SystemUS federal agency
- Study start
- Aug 2001
- Primary completion
- Aug 2005 (actual)
- Study completion
- Aug 2005 (actual)
- First posted
- 15 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient receiving drug eluting or bare metal coronary stents for coronary bifurcation lesions
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- restenosis lesions
- reference side branch artery less than 2mm diameter
- multiple bifurcation lesions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
- Results publicationZamani 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
- Results publication: PubMed 20824754Zamani 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott Kinlay, MBBS, PhD principal investigator
VA Boston Healthcare System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Death, run by VA Boston Healthcare System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00325884, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2024.