COMPETE-LM Trial: Drug-Coated Balloon-Enhanced Provisional Stenting in Complex Left Main Disease.
NCT07408674
Arterial Occlusive Diseases, Arteriosclerosis
View Trial DetailsNCT Number: NCT06446102
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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Notify Me18 year and older
All sexes
Observational
Institut Cardiovasculaire Paris Sud, Hôpital Privé Jacques Cartier, Massy, France
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.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 3 years
Composite of cardiovascular death rate, myocardial infarction rate and target vessel revascularization rate.
Time frame: 3 years
Target lesion revascularization rate
RCF@ICPS
Other
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NCT07408674
Arterial Occlusive Diseases, Arteriosclerosis
View Trial Details