International Bifurcation Study

Recruiting

• Conditions: Coronary Bifurcation Lesion
• Interventions: Procedure: PCI of bifurcation lesions

• Registration Number: NCT03450577
• Lead Sponsor: Meshalkin Research Institute of Pathology of Circulation

Brief 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.

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.

Study Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2018-02-05
• Study First Submitted QC: 2018-02-28
• Study First Posted: 2018-03-01
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-07
• Last Update Posted: 2019-03-11
• Primary Completion: 2021-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PCI of bifurcation lesions	PCI of bifurcation lesions	Patients who have undergone bifurcation coronary artery stenting.

Primary Outcome Measures

Name	Time	Method
Procedural success	1 day	Achievement of technical success and with no in-hospital major adverse cardiac events

Secondary Outcome Measures

Name	Time	Method
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.
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.
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).
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.
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.

Trial Locations

Locations (1)

Meshalkin National Research Center; 🇷🇺 Novosibirsk, Novosibirskaya Oblast, Russian Federation