NCT06446102

Bifurcation Coronary Lesion 0-0-1

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 273 (actual)
• Sponsor: RCF@ICPS · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

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.

Detailed 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.

Conditions

• Coronary Bifurcation Stenosis

Timeline

• Start date: 2023-12-11
• Primary completion: 2023-12-29
• Completion: 2023-12-29
• First posted: 2024-06-06
• Last updated: 2024-06-10

Locations

3 sites across 2 countries: France, Netherlands