International Bifurcation Study

Coronary Bifurcation Lesion Clinical Trial

— IBS  

Official title:

International Prospective Register on Treatment of Coronary Artery Bifurcation Lesions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03450577
• Other study ID #: IBS
• Status: Recruiting
• Start date: January 1, 2018
• Est. completion date: December 31, 2026

Study information

• Verified date: March 2019
• Source: Meshalkin Research Institute of Pathology of Circulation
• Contact: Dmitrii Khelimskii, MD
• Phone: +79137069256
• Email: dkhelim[@]mail.ru
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Bifurcation Lesion

Intervention

Procedure:
• PCI of bifurcation lesions
Different approaches for treatment of bifurcation coronary artery disease.

Locations

Country	Name	City	State
Russian Federation	Meshalkin National Research Center	Novosibirsk	Novosibirskaya Oblast

Sponsors (1)

Lead Sponsor	Collaborator
Meshalkin Research Institute of Pathology of Circulation

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Procedural success	Achievement of technical success and with no in-hospital major adverse cardiac events	1 day
Secondary	Major Adverse Cardiac and Cerebrovascular Events	Death, myocardial infarction (MI), target vessel revascularization (TVR), or stroke.	6 months, 1 year, 3 years, 5 years
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

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