Ignite Creation Date:
2025-12-25 @ 1:07 AM
Ignite Modification Date:
2025-12-25 @ 11:19 PM
Study NCT ID:
NCT06565793
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-12-27
First Post:
2024-08-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A MAajor RAdiation-based PCI Study in STEMI and NSTEMI
Sponsor:
Centre Cardiologique du Nord
Organization:
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:
2024-12
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:
MARAA
Brief Summary:
In France and Italy, approximately 240,000 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 15,630 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:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: