Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2025-12-26 @ 2:35 AM
Study NCT ID:
NCT06446102
Status:
COMPLETED
Last Update Posted:
2024-06-10
First Post:
2024-05-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bifurcation Coronary Lesion 0-0-1
Sponsor:
RCF@ICPS
Organization:
Study Overview
Official Title:
Bifurcation Coronary Lesion 0-0-1
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: