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International Bifurcation Study

ConditionCoronary Bifurcation Lesion
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorMeshalkin Research Institute of Pathology of Circulation

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years

Any type of bifurcation lesion in major epicardial artery

Disqualifiers

Patient refused informed consent to participate in the registry

Trial population

Patients with coronary bifurcation lesion treated during PCI

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • PCI of bifurcation lesions

    Procedure/Surgery

    Different approaches for treatment of bifurcation coronary artery disease.

Treatment groups

5,000 Participants
are divided into 1 treatment group
Group A: PCI of bifurcation lesions1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Meshalkin Research Institute of Pathology of Circulation

Lead sponsor

Source ClinicalTrials.gov
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