Bifurcation Coronary Lesion 0-0-1

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.

Study Overview

• Status: Completed
• Conditions: Coronary Bifurcation Stenosis

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.

• Study Type: Observational
• Enrollment (Actual): 273

Contacts and Locations

Study Locations

• France
  • Massy, France, 91300
    • Institut Cardiovasculaire Paris Sud, Hôpital Privé Jacques Cartier
  • Toulouse, France, 31076
    • Clinique Pasteur
• Netherlands
  • Rotterdam, Netherlands, 3079 DZ
    • Maasstad Ziekenhuis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

In this trial, approximately 300 patients will be recruited from the Hôpital Privé Jacques Cartier in Massy, Clinique Pasteur in Toulouse, and Maasstad Hospital in Rotterdam between 2016 and 2022.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major Adverse Cardiovascular Events	Composite of cardiovascular death rate, myocardial infarction rate and target vessel revascularization rate.	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Target lesion revascularization	Target lesion revascularization rate	3 years

Collaborators and Investigators

• Sponsor: RCF@ICPS
• Investigators: Principal Investigator: Francesca SANGUINETI, MD, ICPS

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2023
• Primary Completion (Actual): December 29, 2023
• Study Completion (Actual): December 29, 2023

Study Registration Dates

• First Submitted: May 17, 2024
• First Submitted That Met QC Criteria: May 31, 2024
• First Posted (Actual): June 6, 2024

Study Record Updates

• Last Update Posted (Actual): June 10, 2024
• Last Update Submitted That Met QC Criteria: June 6, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 23.02718.000229

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No