Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06565793
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-11
Brief Title:
A MAajor RAdiation-based PCI Study in STEMI and NSTEMI
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Impact of Radiation Delivered to the Patient and the Amount of Iodinated Contrast Medium Injected in Complex Versus Noncomplex Percutaneous Coronary Intervention
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MARAA
Brief Summary:
In France and Italy approximately 240000 percutaneous coronary angioplasties PCI are performed annually with an increasing number of complex procedures including those involving the left coronary common trunk a bifurcation chronic occlusion or requiring Rotablator Rotary Atherectomy ARota The medical literature lacks sufficient data regarding several key aspects of complex angioplasty These include the epidemiological characteristics of patients undergoing such procedures the impact of irradiation delivered and the quantity of iodine injected on these lengthy procedures their procedural complication rate and in-hospital mortality
Detailed Description:
A retrospective database of the hemodynamics department of the Centre Cardiologique du Nord and Clinica Mediterranea comprising 15630 consecutive angioplasties performed in unselected patients between February 1 2008 and July 7 2018 was used to identify complex angioplasties and standard angioplasties Two categories of complex angioplasty were identified complex angioplasty with a single complexity criterion and very complex angioplasty with two or more complexity criteria These complex angioplasties were then compared with standard angioplasty angioplasty with no complexity criteria
The following criteria were employed to delineate complex or very complex angioplasties
Unprotected Left Coronary Common Trunk Angioplasty UT-PCI
Angioplasty with Rotablator Rotary Atherectomy ARota-PCI
Angioplasty of Chronic Coronary Occlusion CCO-PCI
Angioplasty of a Bifurcation Lesion CBL-PCI
The following definitions pertain to the classification of angioplasty procedures
Standard angioplasty This encompasses angioplasty procedures that do not meet the criteria for complexity
Complex angioplasty This designation is applied to angioplasty procedures that meet at least one criterion for complexity
Very complex angioplasty This designation is applied to angioplasty procedures that meet at least two criteria for complexity
The following criteria were employed to delineate complex or very complex angioplasties
Unprotected Left Coronary Common Trunk Angioplasty UT-PCI
Angioplasty with Rotablator Rotary Atherectomy ARota-PCI
Angioplasty of Chronic Coronary Occlusion CCO-PCI
Angioplasty of a Bifurcation Lesion CBL-PCI
The following definitions pertain to the classification of angioplasty procedures
Standard angioplasty This encompasses angioplasty procedures that do not meet the criteria for complexity
Complex angioplasty This designation is applied to angioplasty procedures that meet at least one criterion for complexity
Very complex angioplasty This designation is applied to angioplasty procedures that meet at least two criteria for complexity
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None