A MAajor RAdiation-based PCI Study in STEMI and NSTEMI

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorCentre Cardiologique du Nord

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Non Complex PCI

    Device

    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).

  • Complex PCI

    Device

    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.

Treatment groups

15,630 Participants
are divided into 2 treatment groups
Group A: Non Complex PCI1 intervention
Group B: Complex PCI1 intervention

Trial outcomes

Primary outcomes

1

Death

The primary end point of the study is the rate of death

Time frame
30 days
2

Death

The primary end point of the study is the rate of death

Time frame
1 year
3

Death

The primary end point of the study is the rate of death

Time frame
5 years
4

Myocardial Infarction

The primary end point of the study is the rate of myocardial infarction

Time frame
30 days

Secondary outcomes

1

Target Vessel Revascularization

The secondary end point of the study is the rate of target vessel revascularization

Time frame
1 year
2

Target Vessel Revascularization

The secondary end point of the study is the rate of target vessel revascularization

Time frame
5 years
3

Target Lesion Revascularization

The secondary end point of the study is the rate of target lesion revascularization

Time frame
1 year
4

Target Lesion Revascularization

The secondary end point of the study is the rate of target lesion revascularization

Time frame
5 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre Cardiologique du Nord

Lead sponsor

Clinica Mediterranea

Collaborator

This trial is not recruiting at the moment. You can still explore other options: