About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The patient presents with a STEMI or NSTEMI requiring either a non-complex or complex PCI.
Disqualifiers
None
Trial population
* 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.
Trial design
Cohort
Prospective
Treatments tested in this trial
Non Complex PCI
DeviceThe 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).
Complex PCI
DeviceThe 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.
Treatment groups
Trial outcomes
Primary outcomes
Death
The primary end point of the study is the rate of death
Death
The primary end point of the study is the rate of death
Death
The primary end point of the study is the rate of death
Myocardial Infarction
The primary end point of the study is the rate of myocardial infarction
Secondary outcomes
Target Vessel Revascularization
The secondary end point of the study is the rate of target vessel revascularization
Target Vessel Revascularization
The secondary end point of the study is the rate of target vessel revascularization
Target Lesion Revascularization
The secondary end point of the study is the rate of target lesion revascularization
Target Lesion Revascularization
The secondary end point of the study is the rate of target lesion revascularization
Locations
Sponsors and contacts
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Centre Cardiologique du Nord
Lead sponsor
Clinica Mediterranea
Collaborator
This trial is not recruiting at the moment. You can still explore other options: