International Bifurcation Study

NCT03450577 — Recruiting, 5000 participants, Meshalkin Research Institute of Pathology of Circulation

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International Prospective Register on Treatment of Coronary Artery Bifurcation Lesions

Registry	NCT03450577, acronym IBS
Status	Recruiting
Study type	Observational
Enrollment	5000 (Estimated)
Sponsor	Meshalkin Research Institute of Pathology of Circulation (Network)
Conditions	Coronary Bifurcation Lesion
Interventions	PCI of bifurcation lesions (Procedure)
Dates	start 2018-01-01, primary completion 2021-12-31 (estimated), completion 2026-12-31 (estimated), first posted 2018-03-01, last updated 2019-03-11
Locations	1 site in Russia

-Summary

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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
PCI of bifurcation lesions		Procedure: PCI of bifurcation lesions	Patients who have undergone bifurcation coronary artery stenting.

PCI of bifurcation lesions (Procedure): Different approaches for treatment of bifurcation coronary artery disease.

+Outcome measures

Primary outcomes

Procedural success [1 day]: Achievement of technical success and with no in-hospital major adverse cardiac events

Secondary outcomes

Major Adverse Cardiac and Cerebrovascular Events [6 months, 1 year, 3 years, 5 years]: Death, myocardial infarction (MI), target vessel revascularization (TVR), or stroke.
All cause mortality [6 months, 1 year, 3 years, 5 years]: All of the deaths that occur in a study group, regardless of the cause.
Death from cardiac causes [6 months, 1 year, 3 years, 5 years]: All deaths will be assumed cardiovascular in nature unless a non-cardiovascular cause can be clearly provided (e.g. malignancy, trauma, and infection).
Myocardial infarction [6 months, 1 year, 3 years, 5 years]: The presence of electrocardiography findings indicative of ischemia that were not related to the index procedure, as well as chest discomfort associated with creatinine kinase-myocardial band fraction or troponin-T/troponin I greater than the upper limit of normal.
Target vessel revascularization [6 months, 1 year, 3 years, 5 years]: Repeat PCI of the lesion within 5 mm of stent deployment or bypass graft surgery of the target vessel.
Stent thrombosis [6 months, 1 year, 3 years, 5 years]: Sudden occlusion of a stented coronary artery due to formation of thrombosis.According to the Academic Research Consortium was defined as definite, probable, or possible.

+Eligibility

Sex: All, ages: 18 Years to 100 Years

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

+Locations (1)

Facility	City	Country	Status
Meshalkin National Research Center	Novosibirsk, Novosibirsk Oblast	Russia	Recruiting

+Publications

Results publication: 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

+Investigators

Dmitrii Khelimskii, MD, Principal investigator, Meshalkin National Medical Research Center