NCT04471883

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
52mo left

Started Aug 2020

Longer than P75 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress57%
Aug 2020Aug 2030

First Submitted

Initial submission to the registry

July 10, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 15, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

August 15, 2020

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2025

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2030

Expected
Last Updated

July 15, 2020

Status Verified

July 1, 2020

Enrollment Period

5 years

First QC Date

July 10, 2020

Last Update Submit

July 10, 2020

Conditions

Coronary Bifurcation Lesion

Outcome Measures

Primary Outcomes (5)

  • Cardiac Death

    5 years

  • Myocardial Infarction

    5 years

  • Target Lesion Revascularization

    5 years

  • Stent thrombosis

    5 years

  • Major bleeding

    5 years

Interventions

Percutaneous coronary interventionsPROCEDURE

Percutaneous coronary interventions in coronary bifurcation lesions

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Percutaneous Coronary Intervention

Intervention Hierarchy (Ancestors)

Endovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Central Study Contacts

Marcelo A. Abud, M.D

CONTACT

54 11 33085742latambif@gmail.com

Lucio T. Padilla, M.D

CONTACT

latambif@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2020

First Posted

July 15, 2020

Study Start

August 15, 2020

Primary Completion

August 15, 2025

Study Completion (Estimated)

August 15, 2030

Last Updated

July 15, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

No IPD planned