NCT03450577

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Jan 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress93%
Jan 2018Dec 2026

Study Start

First participant enrolled

January 1, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 5, 2018

Completed
24 days until next milestone

First Posted

Study publicly available on registry

March 1, 2018

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

March 11, 2019

Status Verified

March 1, 2019

Enrollment Period

4 years

First QC Date

February 5, 2018

Last Update Submit

March 7, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Procedural success

    Achievement of technical success and with no in-hospital major adverse cardiac events

    1 day

Secondary Outcomes (6)

  • Major Adverse Cardiac and Cerebrovascular Events

    6 months, 1 year, 3 years, 5 years

  • All cause mortality

    6 months, 1 year, 3 years, 5 years

  • Death from cardiac causes

    6 months, 1 year, 3 years, 5 years

  • Myocardial infarction

    6 months, 1 year, 3 years, 5 years

  • Target vessel revascularization

    6 months, 1 year, 3 years, 5 years

  • +1 more secondary outcomes

Study Arms (1)

PCI of bifurcation lesions

Patients who have undergone bifurcation coronary artery stenting.

Procedure: PCI of bifurcation lesions

Interventions

Different approaches for treatment of bifurcation coronary artery disease.

PCI of bifurcation lesions

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with coronary bifurcation lesion treated during PCI

You may qualify if:

  • Age ≥ 18 years
  • Any type of bifurcation lesion in major epicardial artery

You may not qualify if:

  • Patient refused informed consent to participate in the registry

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meshalkin National Research Center

Novosibirsk, Novosibirsk Oblast, 630055, Russia

RECRUITING

Related Publications (1)

  • 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.

Related Links

Study Officials

  • Dmitrii Khelimskii, MD

    Meshalkin National Medical Research Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dmitrii Khelimskii, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
NETWORK
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dmitrii Khelimskii

Study Record Dates

First Submitted

February 5, 2018

First Posted

March 1, 2018

Study Start

January 1, 2018

Primary Completion

December 31, 2021

Study Completion (Estimated)

December 31, 2026

Last Updated

March 11, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations