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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| Major Adverse Cardiovascular Events | Composite of cardiovascular death rate, myocardial infarction rate and target vessel revascularization rate. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Target lesion revascularization | Target lesion revascularization rate | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
- Opposing the collection and processing of necessary data and refusing additional telephone follow-up
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Francesca SANGUINETI, MD | ICPS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Cardiovasculaire Paris Sud, Hôpital Privé Jacques Cartier | Massy | 91300 | France | |||
| Clinique Pasteur |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 16, 2023 | May 17, 2024 | Prot_000.pdf |
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| Toulouse |
| 31076 |
| France |
| Maasstad Ziekenhuis | Rotterdam | 3079 DZ | Netherlands |