International Bifurcation Study (IBS)

International Prospective Register on Treatment of Coronary Artery Bifurcation Lesions

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Bifurcation Lesion
• Intervention / Treatment: Procedure: PCI of bifurcation lesions

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 Type: Observational
• Enrollment (Anticipated): 5000

Contacts and Locations

• Study Contact: Name: Dmitrii Khelimskii, MD; Phone Number: +79137069256; Email: dkhelim@mail.ru

Study Locations

• Russian Federation
  • Novosibirskaya Oblast
    • Novosibirsk, Novosibirskaya Oblast, Russian Federation, 630055
      • Recruiting
      • Meshalkin National Research Center
      • Contact: Dmitrii Khelimskii, MD; Phone Number: +79137069256; Email: dkhelim@mail.ru
      • Contact: Aram Badoyan, MD; Phone Number: +79039319889; Email: soir007@yandex.ru
      • Principal Investigator: Dmitrii Khelimskii, MD
      • Sub-Investigator: Aram Badoyan, MD
      • Sub-Investigator: Oleg Krestyaninov, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with coronary bifurcation lesion treated during PCI

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PCI of bifurcation lesions; Patients who have undergone bifurcation coronary artery stenting.	Procedure: PCI of bifurcation lesions; Different approaches for treatment of bifurcation coronary artery disease.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural success	Achievement of technical success and with no in-hospital major adverse cardiac events	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major Adverse Cardiac and Cerebrovascular Events	Death, myocardial infarction (MI), target vessel revascularization (TVR), or stroke.	6 months, 1 year, 3 years, 5 years
All cause mortality	All of the deaths that occur in a study group, regardless of the cause.	6 months, 1 year, 3 years, 5 years
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).	6 months, 1 year, 3 years, 5 years
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.	6 months, 1 year, 3 years, 5 years
Target vessel revascularization	Repeat PCI of the lesion within 5 mm of stent deployment or bypass graft surgery of the target vessel.	6 months, 1 year, 3 years, 5 years
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.	6 months, 1 year, 3 years, 5 years

Collaborators and Investigators

• Sponsor: Meshalkin Research Institute of Pathology of Circulation
• Investigators: Principal Investigator: Dmitrii Khelimskii, MD, Meshalkin National Medical Research Center

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2026

Study Registration Dates

• First Submitted: February 5, 2018
• First Submitted That Met QC Criteria: February 28, 2018
• First Posted (Actual): March 1, 2018

Study Record Updates

• Last Update Posted (Actual): March 11, 2019
• Last Update Submitted That Met QC Criteria: March 7, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: IBS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No