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International Bifurcation Study (IBS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03450577
Recruitment Status : Recruiting
First Posted : March 1, 2018
Last Update Posted : March 11, 2019
Sponsor:
Information provided by (Responsible Party):
Dmitrii Khelimskii, Meshalkin Research Institute of Pathology of Circulation

Study Description
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Brief 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.


Condition or disease Intervention/treatment
Coronary Bifurcation Lesion 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 Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: International Prospective Register on Treatment of Coronary Artery Bifurcation Lesions
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2026
Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Procedural success [ Time Frame: 1 day ]
    Achievement of technical success and with no in-hospital major adverse cardiac events


Secondary Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with coronary bifurcation lesion treated during PCI
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03450577


Contacts
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Contact: Dmitrii Khelimskii, MD +79137069256 dkhelim@mail.ru

Locations
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Russian Federation
Meshalkin National Research Center Recruiting
Novosibirsk, Novosibirskaya Oblast, Russian Federation, 630055
Contact: Dmitrii Khelimskii, MD    +79137069256    dkhelim@mail.ru   
Contact: Aram Badoyan, MD    +79039319889    soir007@yandex.ru   
Principal Investigator: Dmitrii Khelimskii, MD         
Sub-Investigator: Aram Badoyan, MD         
Sub-Investigator: Oleg Krestyaninov, MD, PhD         
Sponsors and Collaborators
Meshalkin Research Institute of Pathology of Circulation
Investigators
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Principal Investigator: Dmitrii Khelimskii, MD Meshalkin National Medical Research Center
More Information
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Additional Information:

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Responsible Party: Dmitrii Khelimskii, Meshalkin Research Institute of Pathology of Circulation
ClinicalTrials.gov Identifier: NCT03450577    
Other Study ID Numbers: IBS
First Posted: March 1, 2018    Key Record Dates
Last Update Posted: March 11, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No