Coronary Bifurcation LesionNCT04471883
LATAM Bif Registry
An observational study of Coronary Bifurcation Lesion, run by LATAM Bifurcation Club.
Trial summary
The LATAM Bif Registy is an international and prospective registry of percutaneous coronary interventions (PCI) in coronary bifurcation lesions. The main goal of the study is to investigate the current state and long-term outcomes of PCI in this complex subset of coronary lesions in Latin America. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Bifurcation Lesion
- What is being tested?
- Percutaneous coronary interventions
- Type of treatment
- Surgery or procedure
- How many people
- 5,000 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2020to 15 Aug 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Adult, Older adult
Study population: All patients ≥18 years of age, who have at least one significant lesion in a coronary bifurcation on diagnostic cinecoronary angiography and who are candidates to treatment with PCI, regardless of the dedicated-technique used. Those patients who present lesions involving vessels <2 mm by visual estimation and those who refuse to be included in the registry will be excluded.
Who may be able to join
- Age >= 18 years
- Any type of bifurcation lesion
- Side-branch reference diameter >= 2 mm
Who cannot join
- Protected left main disease in patients with previous CABG
- Patients who refuse to be included in the registry
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Lucio T. Padilla, M.D contact
About this study
Official title: Latin American Registry of Percutaneous Interventions in Coronary Bifurcations
The LATAM Bif Registy is an international and prospective registry of percutaneous coronary interventions (PCI) in coronary bifurcation lesions. The main goal of the study is to investigate the current state and long-term outcomes of PCI in this complex subset of coronary lesions in Latin America.
- Conditions
- Coronary Bifurcation Lesion
- Being tested
- Percutaneous coronary interventions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous coronary interventionsProcedure or surgery
Percutaneous coronary interventions in coronary bifurcation lesions
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac Death
Measured: 5 years
Myocardial Infarction
Measured: 5 years
Target Lesion Revascularization
Measured: 5 years
Stent thrombosis
Measured: 5 years
Major bleeding
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2020
- Study start15 Aug 2020 (estimated)
- Primary completion15 Aug 2025 (estimated)
- Study completion15 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Bifurcation LesionStudies 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
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LATAM Bifurcation Club
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04471883
- Sponsor's protocol ID
- 00543186
- Status last verified
- Jul 2020
- First submitted
- 10 Jul 2020
- Last updated
- 15 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD planned
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Latin American Registry of Percutaneous Interventions in Coronary Bifurcations
- ClinicalTrials.gov ID
- NCT04471883
- Acronym / sponsor ID
- 00543186
- Conditions
- Coronary Bifurcation Lesion
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- LATAM Bifurcation ClubResearch network
- Study start
- 15 Aug 2020 (estimated)
- Primary completion
- 15 Aug 2025 (estimated)
- Study completion
- 15 Aug 2030 (estimated)
- First posted
- 15 Jul 2020 (actual)
- 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 LATAM Bif Registy is an international and prospective registry of percutaneous coronary interventions (PCI) in coronary bifurcation lesions. The main goal of the study is to investigate the current state and long-term outcomes of PCI in this complex subset of coronary lesions in Latin America.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients ≥18 years of age, who have at least one significant lesion in a coronary bifurcation on diagnostic cinecoronary angiography and who are candidates to treatment with PCI, regardless of the dedicated-technique used. Those patients who present lesions involving vessels <2 mm by visual estimation and those who refuse to be included in the registry will be excluded.
Key inclusion criteria (3 listed)
- Age >= 18 years
- Any type of bifurcation lesion
- Side-branch reference diameter >= 2 mm
Key exclusion criteria (2 listed)
- Protected left main disease in patients with previous CABG
- Patients who refuse to be included in the registry
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous coronary interventionsPercutaneous coronary interventions in coronary bifurcation lesions | Procedure or surgery | – |
Primary outcome
Cardiac Death
Time frame: 5 years
Myocardial Infarction
Time frame: 5 years
Target Lesion Revascularization
Time frame: 5 years
Stent thrombosis
Time frame: 5 years
Major bleeding
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2020.
- Individual participant dataSharing planned: No. No IPD planned
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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.
Lucio T. Padilla, M.D contact
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Bifurcation Lesion, run by LATAM Bifurcation Club.
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 3 inclusion and 2 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: opening soon, as of the sponsor's last update on 15 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marcelo A. Abud, M.D (54 11 33085742, latambif@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac Death (time frame: 5 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jul 2020.