Trials / Not Yet Recruiting

Not Yet RecruitingNCT06565793

A MAajor RAdiation-based PCI Study in STEMI and NSTEMI

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
Phase: —
Study type: Observational
Enrollment: 15,630 (estimated)

Sponsor: Centre Cardiologique du Nord · Academic / Other
Sex: All
Age: 18 Years – 90 Years
Healthy volunteers: Not accepted

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.

Conditions

Interventions

Type	Name	Description
DEVICE	Non Complex PCI	The patient cohort included individuals who had been hospitalized with a diagnosis of either STEMI or non-STEMI. The procedure involved percutaneous coronary intervention (PCI) with the use of drug-eluting stents (DES).
DEVICE	Complex PCI	The patient cohort included individuals who had been hospitalized with a diagnosis of either STEMI or non-STEMI. The procedure involved complex percutaneous coronary intervention (PCI) with the use of drug-eluting stents (DES).This designation is applied to angioplasty procedures that meet at least one criterion for complexity. The complex angioplasty involved patients with unprotected left coronary common trunk (UT-PCI), the use of rotablator rotary atherectomy (ARota-PCI), the angioplasty of chronic coronary occlusion (CCO-PCI), or the angioplasty of a bifurcation lesion (CBL-PCI).The highly intricate angioplasty procedure was conducted on patients who met at least two criteria indicative of complexity.

Timeline

Start date: 2025-03-01
Primary completion: 2025-07-01
Completion: 2025-12-31
First posted: 2024-08-22
Last updated: 2024-12-27

Regulatory

FDA-regulated device study

Source: ClinicalTrials.gov record NCT06565793. Inclusion in this directory is not an endorsement.