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RecruitingNCT03450577IBSUpdated Mar 11, 2019

International Bifurcation Study

An observational study in Coronary Bifurcation Lesion, sponsored by Meshalkin Research Institute of Pathology of Circulation. Recruiting at 1 site in Russia. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2019-03-11.

Sponsored by Meshalkin Research Institute of Pathology of Circulation · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2021, 4 years 9 months ago, but the record still lists the study as recruiting.
  • Started Jan 2018; still recruiting 8 years 9 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
5,000
Ages
18 Years to 100 Years
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • Coronary Bifurcation Lesion
03

In context

Lead sponsor

Meshalkin Research Institute of Pathology of Circulation is the lead sponsor of 118 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with coronary bifurcation lesion treated during PCI

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patient refused informed consent to participate in the registry
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
5,000 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes

Groups and cohorts

  • PCI of bifurcation lesions

    Patients who have undergone bifurcation coronary artery stenting.

    Procedure: PCI of bifurcation lesions

Interventions

  • ProcedurePCI of bifurcation lesions

    Different approaches for treatment of bifurcation coronary artery disease.

06

What researchers measure

Primary outcomes

  1. Procedural success

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

    Time frame: 1 day

Secondary outcomes

  1. Major Adverse Cardiac and Cerebrovascular Events

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

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

  2. All cause mortality

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

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

  3. Death from cardiac causes

    All deaths will be assumed cardiovascular in nature unless a non-cardiovascular cause can be clearly provided (e.g. malignancy, trauma, and infection).

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

  4. Myocardial infarction

    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.

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

  5. Target vessel revascularization

    Repeat PCI of the lesion within 5 mm of stent deployment or bypass graft surgery of the target vessel.

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

  6. Stent thrombosis

    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.

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

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Study locations

1 of 1 sites recruiting
  • Meshalkin National Research Center
    Novosibirsk, Novosibirsk Oblast 630055, Russia
    • Dmitrii Khelimskii, MD · Contact · dkhelim@mail.ru · +79137069256
    • Aram Badoyan, MD · Contact · soir007@yandex.ru · +79039319889
    • Dmitrii Khelimskii, MD · Principal investigator
    • Aram Badoyan, MD · Sub investigator
    • Oleg Krestyaninov, MD, PhD · Sub investigator
    Recruiting
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References and documents

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. PubMed 38871947 ↗

Related links

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 11, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03450577
Responsible party
Dmitrii Khelimskii (Dmitrii Khelimskii, Meshalkin Research Institute of Pathology of Circulation) — Principal investigator
First posted
Mar 1, 2018
Start date
Jan 1, 2018
Primary completion
Dec 31, 2021 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Mar 11, 2019

Study contacts

Dmitrii Khelimskii, MD
Contact
dkhelim@mail.ru
+79137069256
Dmitrii Khelimskii, MD
principal investigator · Meshalkin National Medical Research Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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