LATAM Bif Registry

July 10, 2020 updated by: LATAM Bifurcation Club

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • Age >= 18 years
  • Any type of bifurcation lesion
  • Side-branch reference diameter >= 2 mm

Exclusion Criteria:

  • Protected left main disease in patients with previous CABG
  • Patients who refuse to be included in the registry

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Stent thrombosis
Time Frame: 5 years
5 years
Myocardial Infarction
Time Frame: 5 years
5 years
Target Lesion Revascularization
Time Frame: 5 years
5 years
Cardiac Death
Time Frame: 5 years
5 years
Major bleeding
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LATAM Bifurcation Club

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 15, 2020

Primary Completion (Anticipated)

August 15, 2025

Study Completion (Anticipated)

August 15, 2030

Study Registration Dates

First Submitted

July 10, 2020

First Submitted That Met QC Criteria

July 10, 2020

First Posted (Actual)

July 15, 2020

Study Record Updates

Last Update Posted (Actual)

July 15, 2020

Last Update Submitted That Met QC Criteria

July 10, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 00543186

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No IPD planned

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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