A MAajor RAdiation-based PCI Study in STEMI and NSTEMI

Not yet recruiting

• Conditions: Radiation Toxicity; Coronary Occlusion; Coronary Stenosis; Coronary Artery Calcification; Coronary Syndrome; Myocardial Infarction (MI); Coronary Thrombosis; Coronary Artery Disease
• Interventions: Device: Complex PCI; Device: Non Complex PCI

• Registration Number: NCT06565793
• Lead Sponsor: Centre Cardiologique du Nord

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.

Study Timeline

• Study First Submitted: 2024-08-11
• Study First Submitted QC: 2024-08-21
• Study First Posted: 2024-08-22
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-21
• Last Update Posted: 2024-12-27
• Study Start: 2025-03-01
• Primary Completion: 2025-07-01
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 15630

Inclusion Criteria

• The patient presents with a STEMI or NSTEMI requiring either a non-complex or complex PCI.

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Complex PCI	Complex PCI	This study focuses on patients diagnosed with either STEMI or NSTEMI who have undergone complex percutaneous coronary intervention (PCI) with the use of drug-eluting stents (DES).The following criteria were used to distinguish between complex and very complex angioplasty cases: The following procedures have been identified as complex or very complex: * Unprotected Left Coronary Common Trunk Angioplasty (UT-PCI) * Angioplasty with Rotablator Rotary Atherectomy (ARota-PCI) * Angioplasty of Chronic Coronary Occlusion (CCO-PCI)
Non Complex PCI	Non Complex PCI	The objective of this study is to examine the efficacy of percutaneous coronary intervention (PCI) with the use of drug-eluting stents (DES) in patients diagnosed with ST-Elevation Myocardial Infarction (STEMI) or Non-ST-Elevation Myocardial Infarction (NSTEMI).

Primary Outcome Measures

Name	Time	Method
Stent Thrombosis	5 years	The primary end point of the study is the rate of stent thrombosis
Death	5 years	The primary end point of the study is the rate of death
Acute Kidney Injury	1 years	The primary end point of the study is the rate of acute kidney injury
Coronary Obstruction Requiring Intervention	5 years	The primary end point of the study is the rate of coronary obstruction requiring intervention
Increase in Tnl and Tnt Levels	1 year	The primary end point of the study is the rate in increase of Tnl and Tnt levels
Rehospitalization	5 years	The primary end point of the study is the rate of rehospitalization (coronary-related or procedure-related, including heart failure)
Myocardial Infarction	5 years	The primary end point of the study is the rate of myocardial infarction

Secondary Outcome Measures

Name	Time	Method
Target Lesion Revascularization	5 years	The secondary end point of the study is the rate of target lesion revascularization
Target Vessel Revascularization	5 years	The secondary end point of the study is the rate of target vessel revascularization