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NCT Number: NCT03450577

International Bifurcation Study

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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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Meshalkin National Research Center

Novosibirsk, Novosibirsk Oblast, 630055, Russia

Location status: Recruiting

Location contact

Aram Badoyan, MD

CONTACT

[email protected]

+79039319889

Aram Badoyan, MD

SUB_INVESTIGATOR

Dmitrii Khelimskii, MD

CONTACT

[email protected]

+79137069256

Dmitrii Khelimskii, MD

PRINCIPAL_INVESTIGATOR

Oleg Krestyaninov, MD, PhD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PCI of bifurcation lesions

Procedure

Different approaches for treatment of bifurcation coronary artery disease.

Primary outcomes

  1. Procedural success

    Time frame: 1 day

    Achievement of technical success and with no in-hospital major adverse cardiac events

Secondary outcomes

  1. Major Adverse Cardiac and Cerebrovascular Events

    Time frame: 6 months, 1 year, 3 years, 5 years

    Death, myocardial infarction (MI), target vessel revascularization (TVR), or stroke.

  2. All cause mortality

    Time frame: 6 months, 1 year, 3 years, 5 years

    All of the deaths that occur in a study group, regardless of the cause.

  3. Death from cardiac causes

    Time frame: 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).

  4. Myocardial infarction

    Time frame: 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.

  5. Target vessel revascularization

    Time frame: 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.

  6. Stent thrombosis

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dmitrii Khelimskii, MD

CONTACT

[email protected]

+79137069256

Sponsors and collaborators

Lead sponsor

Meshalkin Research Institute of Pathology of Circulation

Network

Registry information

Official study title

International Prospective Register on Treatment of Coronary Artery Bifurcation Lesions

Acronym: IBS

Important dates

Study start
2018
Primary completion
2021
Study completion
2026
First posted
Mar 1, 2018
Registry last updated
Mar 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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