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Completed

NCT Number: NCT06446102

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institut Cardiovasculaire Paris Sud, Hôpital Privé Jacques Cartier, Massy, France

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Major Adverse Cardiovascular Events

    Time frame: 3 years

    Composite of cardiovascular death rate, myocardial infarction rate and target vessel revascularization rate.

Secondary outcomes

  1. Target lesion revascularization

    Time frame: 3 years

    Target lesion revascularization rate

Sponsors and collaborators

Lead sponsor

RCF@ICPS

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jun 6, 2024
Registry last updated
Jun 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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