Prospective Australasian National Bifurcation Coronary Intervention Outcomes Registry
Prospective Australasian National Bifurcation Coronary Intervention Outcomes Registry comparing provisional strategy to 2 stent strategy.
Northern Sydney Local Health District
1,750 participants
Aug 21, 2023
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
Inclusion Criteria6
- years and older.
- Coronary bifurcation according to the Medina classification of bifurcations (1,1,1; 1,0,0; 1,1,0; 1,0,1; 0,1,1; 0,1,0).
- Main branch diameter greater than or equal to 2.5mm and side branch diameter greater than or equal to 2mm.
- Lesion severity greater than or equal to 70% stenosis, positive pressure wire assessment (FFR less than or equal to 0.8; iFR<0.9), culprit lesion for ST-elevation myocardial infarction (STEMI) or Non-STEMI (NSTEMI), or positive functional assessment in the territory being revascularized.
- Treated with either a provisional or 2 stent strategy.
- Treated with drug-eluting stents.
Exclusion Criteria5
- Age less than 18 years
- Cardiogenic Shock
- Allergy/intolerance to anti-platelet medication
- Less than 1 year expected survival
- Active bleeding disorder
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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 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)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12624000143527