Bifurcation Coronary Lesion 0-0-1

RCF@ICPS

Status: Completed

Conditions: Coronary Bifurcation Stenosis

Study type: Observational

Funder types: Other

Identifiers

NCT06446102

23.02718.000229

Details and patient eligibility

About

Research Involving Human Persons (RIHP 3) focusing on the treatment of type 0-0-1 bifurcation lesions in routine practice. Multicenter Study.

To retrieve and analyze the details of different angioplasty techniques used in this type of bifurcation lesion (Medina 0-0-1) in order to describe current practice and search for predictors of clinical events.

Full description

The primary objective of the trial is to estimate the frequency of Major Adverse Cardiac Events (MACE), including cardiac death, myocardial infarction within the territory of the treated lesion, and revascularization of the target lesion in a representative population of patients treated by coronary angioplasty of type 0-0-1 bifurcation lesions.

The sample size will be determined by the number of angioplasties of type 0-0-1 bifurcation lesions performed at each center between 2016 and 2022.

Since the trial is observational in nature and there are no previously published studies, the sample size cannot be calculated based on the desired precision of the estimation.

Furthermore, the purpose of the study is also to assess the techniques used to treat this type of coronary bifurcation and to highlight any differences between different centers and with other types of coronary bifurcation lesions described in the literature.

Enrollment: 273 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female aged 18 years and older,
• Who underwent angioplasty for a coronary bifurcation lesion of type 0-0-1 between 2016 and 2022.

Exclusion criteria

• Opposing the collection and processing of necessary data and refusing additional telephone follow-up

Trial design