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International Bifurcation Study

International Prospective Register on Treatment of Coronary Artery Bifurcation Lesions

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03450577
Acronym
IBS
Enrollment
5000
Registered
2018-03-01
Start date
2018-01-01
Completion date
2026-12-31
Last updated
2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Bifurcation Lesion

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.

Interventions

PROCEDUREPCI of bifurcation lesions

Different approaches for treatment of bifurcation coronary artery disease.

Sponsors

Meshalkin Research Institute of Pathology of Circulation
Lead SponsorNETWORK

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Procedural success1 dayAchievement of technical success and with no in-hospital major adverse cardiac events

Secondary

MeasureTime frameDescription
All cause mortality6 months, 1 year, 3 years, 5 yearsAll of the deaths that occur in a study group, regardless of the cause.
Death from cardiac causes6 months, 1 year, 3 years, 5 yearsAll deaths will be assumed cardiovascular in nature unless a non-cardiovascular cause can be clearly provided (e.g. malignancy, trauma, and infection).
Major Adverse Cardiac and Cerebrovascular Events6 months, 1 year, 3 years, 5 yearsDeath, myocardial infarction (MI), target vessel revascularization (TVR), or stroke.
Target vessel revascularization6 months, 1 year, 3 years, 5 yearsRepeat PCI of the lesion within 5 mm of stent deployment or bypass graft surgery of the target vessel.
Stent thrombosis6 months, 1 year, 3 years, 5 yearsSudden occlusion of a stented coronary artery due to formation of thrombosis.According to the Academic Research Consortium was defined as definite, probable, or possible.
Myocardial infarction6 months, 1 year, 3 years, 5 yearsThe 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.

Countries

Russia

Contacts

Primary ContactDmitrii Khelimskii, MD
dkhelim@mail.ru+79137069256

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026