Coronary Bifurcation LesionIBSNCT03450577
International Bifurcation Study
An observational study of Coronary Bifurcation Lesion, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Coronary Bifurcation Lesion
- What is being tested?
- PCI of bifurcation lesions
- Type of treatment
- Surgery or procedure
- How many people
- 5,000 participants
- Where
- 1 siteRussia
- Study dates
- 1 Jan 2018to 31 Dec 2026
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with coronary bifurcation lesion treated during PCI
Who may be able to join
- Age ≥ 18 years
- Any type of bifurcation lesion in major epicardial artery
Who cannot join
- Patient refused informed consent to participate in the registry
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
Meshalkin National Research Center
Novosibirsk, Novosibirsk Oblast, 630055
Dmitrii Khelimskii, MD, +79137069256, dkhelim@mail.ru
Aram Badoyan, MD, +79039319889, soir007@yandex.ru
About this study
Official title: 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.
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.
- Conditions
- Coronary Bifurcation Lesion
- Being tested
- PCI of bifurcation lesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCI of bifurcation lesionsProcedure or surgery
Different approaches for treatment of bifurcation coronary artery disease.
| Study group | Role | What they receive |
|---|---|---|
| PCI of bifurcation lesions | Patients who have undergone bifurcation coronary artery stenting. Receives: Procedure: PCI of bifurcation lesions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural success
Achievement of technical success and with no in-hospital major adverse cardiac events
Measured: 1 day
Secondary outcomes (6)
Major Adverse Cardiac and Cerebrovascular Events
Death, myocardial infarction (MI), target vessel revascularization (TVR), or stroke.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months, 1 year, 3 years, 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2018
- Study start1 Jan 2018
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Bifurcation LesionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Meshalkin Research Institute of Pathology of Circulation
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Dmitrii Khelimskii, Meshalkin Research Institute of Pathology of Circulation
- Investigators
- Dmitrii Khelimskii, MD, Principal investigator, Meshalkin National Medical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03450577
- Sponsor's protocol ID
- IBS
- Acronym
- IBS
- Status last verified
- Mar 2019
- First submitted
- 5 Feb 2018
- Last updated
- 11 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Prospective Register on Treatment of Coronary Artery Bifurcation Lesions
- ClinicalTrials.gov ID
- NCT03450577
- Acronym / sponsor ID
- IBS / IBS
- Conditions
- Coronary Bifurcation Lesion
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Meshalkin Research Institute of Pathology of CirculationResearch network
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 1 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PCI of bifurcation lesions | – | Procedure: PCI of bifurcation lesionsPatients who have undergone bifurcation coronary artery stenting. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with coronary bifurcation lesion treated during PCI
Key inclusion criteria (2 listed)
- Age ≥ 18 years
- Any type of bifurcation lesion in major epicardial artery
Key exclusion criteria (1 listed)
- Patient refused informed consent to participate in the registry
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PCI of bifurcation lesionsDifferent approaches for treatment of bifurcation coronary artery disease. | Procedure or surgery | PCI of bifurcation lesions |
Primary outcome
Procedural success
Time frame: 1 day
Achievement of technical success and with no in-hospital major adverse cardiac events
6 secondary outcomes
Major Adverse Cardiac and Cerebrovascular Events
Time frame: 6 months, 1 year, 3 years, 5 years
All cause mortality
Time frame: 6 months, 1 year, 3 years, 5 years
Death from cardiac causes
Time frame: 6 months, 1 year, 3 years, 5 years
Myocardial infarction
Time frame: 6 months, 1 year, 3 years, 5 years
Target vessel revascularization
Time frame: 6 months, 1 year, 3 years, 5 years
Stent thrombosis
Time frame: 6 months, 1 year, 3 years, 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2019.
- Derived from this study: PubMed 38871947Khelimskii 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dmitrii Khelimskii, MD principal investigator
Meshalkin National Medical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Bifurcation Lesion, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dmitrii Khelimskii, MD (+79137069256, dkhelim@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedural success (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03450577, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2019.