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Bifurcation Coronary Lesion 0-0-1

Bifurcation Coronary Lesion 0-0-1

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06446102
Enrollment
273
Registered
2024-06-06
Start date
2023-12-11
Completion date
2023-12-29
Last updated
2024-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Bifurcation Stenosis

Brief 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.

Interventions

None listed

Sponsors

RCF@ICPS
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
Major Adverse Cardiovascular Events3 yearsComposite of cardiovascular death rate, myocardial infarction rate and target vessel revascularization rate.

Secondary

MeasureTime frameDescription
Target lesion revascularization3 yearsTarget lesion revascularization rate

Countries

France, Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026