Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06446102 |
| Other study ID # |
23.02718.000229 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
December 11, 2023 |
| Est. completion date |
December 29, 2023 |
Study information
| Verified date |
June 2024 |
| Source |
RCF@ICPS |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
