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NCT Number: NCT06565793

A MAajor RAdiation-based PCI Study in STEMI and NSTEMI

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.

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Key information

Conditions

Myocardial Infarction (MI) Angina Pectoris Angina, Unstable Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Chest Pain Coronary Artery Calcification Coronary Artery Disease Coronary Disease Coronary Occlusion Coronary Stenosis Coronary Syndrome Coronary Thrombosis Embolism and Thrombosis Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Radiation Injuries Radiation Toxicity Signs and Symptoms Thrombosis Vascular Diseases Wounds and Injuries

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-

Treatment and study plan

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.

Primary outcomes

  1. Death

    Time frame: 30 days

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

  2. Death

    Time frame: 1 year

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

  3. Death

    Time frame: 5 years

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

  4. Myocardial Infarction

    Time frame: 30 days

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

  5. Myocardial Infarction

    Time frame: 1 year

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

  6. Myocardial Infarction

    Time frame: 5 years

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

  7. Stent Thrombosis

    Time frame: 30 days

    The primary end point of the study is the rate of stent thrombosis

  8. Stent Thrombosis

    Time frame: 1 year

    The primary end point of the study is the rate of stent thrombosis

  9. Stent Thrombosis

    Time frame: 5 years

    The primary end point of the study is the rate of stent thrombosis

  10. Acute Kidney Injury

    Time frame: 30 days

    The primary end point of the study is the rate of acute kidney injury

  11. Acute Kidney Injury

    Time frame: 1 years

    The primary end point of the study is the rate of acute kidney injury

  12. Coronary Obstruction Requiring Intervention

    Time frame: 30 days

    The primary end point of the study is the rate of coronary obstruction requiring intervention

  13. Coronary Obstruction Requiring Intervention

    Time frame: 1 year

    The primary end point of the study is the rate of coronary obstruction requiring intervention

  14. Coronary Obstruction Requiring Intervention

    Time frame: 5 years

    The primary end point of the study is the rate of coronary obstruction requiring intervention

  15. Increase in Tnl and Tnt Levels

    Time frame: 30 days

    The primary end point of the study is the rate in increase of Tnl and Tnt levels

  16. Increase in Tnl and Tnt Levels

    Time frame: 1 year

    The primary end point of the study is the rate in increase of Tnl and Tnt levels

  17. Rehospitalization

    Time frame: 30 days

    The primary end point of the study is the rate of rehospitalization (coronary-related or procedure-related, including heart failure)

  18. Rehospitalization

    Time frame: 1 year

    The primary end point of the study is the rate of rehospitalization (coronary-related or procedure-related, including heart failure)

  19. Rehospitalization

    Time frame: 5 years

    The primary end point of the study is the rate of rehospitalization (coronary-related or procedure-related, including heart failure)

Secondary outcomes

  1. Target Vessel Revascularization

    Time frame: 1 year

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

  2. Target Vessel Revascularization

    Time frame: 5 years

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

  3. Target Lesion Revascularization

    Time frame: 1 year

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

  4. Target Lesion Revascularization

    Time frame: 5 years

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

Study contacts

Contact information is provided by the study sponsor or research team.

Francesco Nappi, MD

CONTACT

[email protected]

782298823 ext. +33

Francesco Nappi, MD

CONTACT

[email protected]

49334119 ext. +33

Sponsors and collaborators

Lead sponsor

Centre Cardiologique du Nord

Other

Collaborators

  • Clinica Mediterranea

Registry information

Official study title

The Impact of Radiation Delivered to the Patient and the Amount of Iodinated Contrast Medium Injected in Complex Versus Noncomplex Percutaneous Coronary Intervention.

Acronym: MARAA

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 22, 2024
Registry last updated
Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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