RecruitingACTRN12624000143527

Prospective Australasian National Bifurcation Coronary Intervention Outcomes Registry

Prospective Australasian National Bifurcation Coronary Intervention Outcomes Registry comparing provisional strategy to 2 stent strategy.


Sponsor

Northern Sydney Local Health District

Enrollment

1,750 participants

Start Date

Aug 21, 2023

Study Type

Observational

Conditions

Summary

Despite the substantial volume of bifurcation PCI which is performed in ANZ, there is no local registry in which procedural techniques, device usage, and outcomes are documented. The study is observational in nature only, with PCI selection and technique will be left at the discretion of the operator. Eligible subjects will be enrolled into the registry after providing informed consent. Medical records review and phone call follow up will be performed to assess for the incidence of the primary and secondary outcome at 72hrs (medical record only), 3 months, 1 year and 2 years.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is building a detailed registry to track how blocked coronary artery bifurcations — points where a heart artery splits into two branches — are treated across Australia and New Zealand. When plaque builds up at these junctions, it creates one of the trickier challenges in heart stenting procedures, and there is currently no shared database recording what techniques are used and how patients fare afterward. The registry is observational only, meaning doctors will continue treating patients exactly as they normally would. The study simply records what was done and follows up on outcomes at 72 hours, 3 months, 1 year, and 2 years to understand which approaches work best in real-world practice. You may be eligible if you are 18 or older and have significant blockage (70% or more) in a bifurcation artery, or if that artery is the culprit in a heart attack. You must be treated with drug-eluting stents. People in cardiogenic shock, with active bleeding disorders, or with allergy to antiplatelet medications are not eligible.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

All patients recruited to this study require a stenting procedure as clinically indicated to coronary disease occurring at a bifurcation. Patients will present with stable angina, acute coronary syndr

All patients recruited to this study require a stenting procedure as clinically indicated to coronary disease occurring at a bifurcation. Patients will present with stable angina, acute coronary syndromes, or other indications, and need to have severe coronary disease either angiographically or based on functional assessment. Patient selection and the technique will be left completely at the discretion of the operator, with a provisional (one-stent) technique and a 2-stent technique being the main bifurcation stenting sub-groups. Participants will be asked to provide informed consent after being provided a patient information sheet and the opportunity to discuss questions about the study. Patients will receive a phone call at 3 months, 1 year and 2 years to assess if they have any symptoms or presentations to hospital which may indicate target lesion failure.


Locations(1)

New Zealand

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ACTRN12624000143527