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Recruiting NCT03450577

International Bifurcation Study

Observational Coronary Bifurcation Lesion

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PCI of bifurcation lesions.
Who it may be relevant to
Registry conditions: Coronary Bifurcation Lesion. Basic parameters: 18 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Russia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

International Prospective Register on Treatment of Coronary Artery Bifurcation Lesions

Overview

The IBS registry is an observational, multi-center, real-world registry of stenting in coronary bifurcation lesions that will collect information on procedures and outcomes from various participating centers. The aim of this registry is to investigate long-term clinical results and predictors of adverse outcomes after PCI for coronary bifurcation lesions among various participating centers.

Detailed description

Patients with coronary bifurcation lesions, if they meets all the study inclusion criteria and none of the exclusion criteria, after signing the informed consent, they will underwent PCI according to the current standard of care and will be entered in the registry. Follow-up for all subjects will continue for 5 years.

Interventions

  • Procedure PCI of bifurcation lesions
    Different approaches for treatment of bifurcation coronary artery disease.

Primary outcome measures

  • Procedural success [Time frame: 1 day]
Secondary outcome measures (6)
  • Major Adverse Cardiac and Cerebrovascular Events [Time frame: 6 months, 1 year, 3 years, 5 years]
  • All cause mortality [Time frame: 6 months, 1 year, 3 years, 5 years]
  • Death from cardiac causes [Time frame: 6 months, 1 year, 3 years, 5 years]
  • Myocardial infarction [Time frame: 6 months, 1 year, 3 years, 5 years]
  • Target vessel revascularization [Time frame: 6 months, 1 year, 3 years, 5 years]
  • Stent thrombosis [Time frame: 6 months, 1 year, 3 years, 5 years]

Eligibility criteria

Inclusion criteria

  • Age ≥ 18 years
  • Any type of bifurcation lesion in major epicardial artery

Exclusion criteria

  • Patient refused informed consent to participate in the registry

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Russia · 1 center
  • Meshalkin National Research Center — Novosibirsk

Publications

  • Khelimskii D, Bessonov I, Sapozhnikov S, Badoyan A, Baranov A, Mamurjon M, Manukian S, Utegenov R, Krestyaninov O. Impact of Prolonged Dual Antiplatelet Therapy After Bifurcation Percutaneous Coronary Intervention in Patients with High Ischemic Risk. Am J Cardiovasc Drugs. 2024 Jul;24(4):577-588. doi: 10.1007/s40256-024-00657-1. Epub 2024 Jun 13. PMID 38871947

Identifiers

NCT: NCT03450577 · IBS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗