Myocardial Infarction (MI)MARAANCT06565793
A MAajor RAdiation-based PCI Study in STEMI and NSTEMI
An observational study of Myocardial Infarction (MI) and Radiation Toxicity, run by Centre Cardiologique du Nord at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Myocardial Infarction (MI), Radiation Toxicity, Coronary Stenosis
- What is being tested?
- Non Complex PCI and Complex PCI
- Type of treatment
- Medical device
- How many people
- 15,630 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2025to 31 Dec 2028
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- The patient presents with a STEMI or NSTEMI requiring either a non-complex or complex PCI.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Radiation Delivered to the Patient and the Amount of Iodinated Contrast Medium Injected in Complex Versus Noncomplex Percutaneous Coronary Intervention.
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.
Read the 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
- Myocardial Infarction (MI), Radiation Toxicity, Coronary Stenosis, Coronary Thrombosis, Coronary Artery Calcification, Coronary Occlusion
- Being tested
- Non Complex PCI, Complex PCI
- Keywords
- PCI,DES, Radiation
- Medical subject headings
- Myocardial Infarction, Radiation Injuries, Coronary Stenosis, Coronary Thrombosis, Coronary Occlusion, Angina, Unstable, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non Complex PCIDevice
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 PCIDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: Non 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) Receives: Device: Complex PCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
The primary end point of the study is the rate of death
Measured: 30 days
Death
The primary end point of the study is the rate of death
Measured: 1 year
Death
The primary end point of the study is the rate of death
Measured: 5 years
Myocardial Infarction
The primary end point of the study is the rate of myocardial infarction
Measured: 30 days
Myocardial Infarction
The primary end point of the study is the rate of myocardial infarction
Measured: 1 year
Myocardial Infarction
The primary end point of the study is the rate of myocardial infarction
Measured: 5 years
Stent Thrombosis
The primary end point of the study is the rate of stent thrombosis
Measured: 30 days
Stent Thrombosis
The primary end point of the study is the rate of stent thrombosis
Measured: 1 year
Stent Thrombosis
The primary end point of the study is the rate of stent thrombosis
Measured: 5 years
Acute Kidney Injury
The primary end point of the study is the rate of acute kidney injury
Measured: 30 days
Acute Kidney Injury
The primary end point of the study is the rate of acute kidney injury
Measured: 1 years
Coronary Obstruction Requiring Intervention
The primary end point of the study is the rate of coronary obstruction requiring intervention
Measured: 30 days
Coronary Obstruction Requiring Intervention
The primary end point of the study is the rate of coronary obstruction requiring intervention
Measured: 1 year
Coronary Obstruction Requiring Intervention
The primary end point of the study is the rate of coronary obstruction requiring intervention
Measured: 5 years
Increase in Tnl and Tnt Levels
The primary end point of the study is the rate in increase of Tnl and Tnt levels
Measured: 30 days
Increase in Tnl and Tnt Levels
The primary end point of the study is the rate in increase of Tnl and Tnt levels
Measured: 1 year
Rehospitalization
The primary end point of the study is the rate of rehospitalization (coronary-related or procedure-related, including heart failure)
Measured: 30 days
Rehospitalization
The primary end point of the study is the rate of rehospitalization (coronary-related or procedure-related, including heart failure)
Measured: 1 year
Rehospitalization
The primary end point of the study is the rate of rehospitalization (coronary-related or procedure-related, including heart failure)
Measured: 5 years
Secondary outcomes (4)
Target Vessel Revascularization
The secondary end point of the study is the rate of target vessel revascularization
Measured: 1 year
Target Vessel Revascularization
The secondary end point of the study is the rate of target vessel revascularization
Measured: 5 years
Target Lesion Revascularization
The secondary end point of the study is the rate of target lesion revascularization
Measured: 1 year
Target Lesion Revascularization
The secondary end point of the study is the rate of target lesion revascularization
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2024
- Study start1 Mar 2025
- Primary completion1 May 2026
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial Infarction (MI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15,630 participants (actual)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Centre Cardiologique du Nord
- Sponsor type
- University, hospital or other
- Collaborators
- Clinica Mediterranea
- Responsible party
- Principal investigator, Francesco Nappi, Centre Cardiologique du Nord
- Investigators
- Francesco Nappi, MD, Principal investigator, Centre Cardiologique du Nord
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06565793
- Sponsor's protocol ID
- ID: CN-08-24
- Acronym
- MARAA
- Status last verified
- Jul 2026
- First submitted
- 11 Aug 2024
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Radiation Delivered to the Patient and the Amount of Iodinated Contrast Medium Injected in Complex Versus Noncomplex Percutaneous Coronary Intervention.
- ClinicalTrials.gov ID
- NCT06565793
- Acronym / sponsor ID
- MARAA / ID: CN-08-24
- Conditions
- Myocardial Infarction (MI), Radiation Toxicity, Coronary Stenosis, Coronary Thrombosis, Coronary Artery Calcification, Coronary Occlusion
- Keywords
- PCI,DES, Radiation
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 15,630 participants (actual)
- Lead sponsor
- Centre Cardiologique du NordUniversity, hospital or other
- Collaborators
- Clinica Mediterranea
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 1 May 2026 (actual)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 22 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non Complex PCI | – | Device: Non Complex PCIThe 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). |
| Complex PCI | – | Device: Complex PCIThis 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) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (1 listed)
- The patient presents with a STEMI or NSTEMI requiring either a non-complex or complex PCI.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non Complex PCIThe 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 | Non Complex PCI |
| Complex PCIThe 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. | Device | Complex PCI |
Primary outcome
Death
Time frame: 30 days
The primary end point of the study is the rate of death
Death
Time frame: 1 year
The primary end point of the study is the rate of death
Death
Time frame: 5 years
The primary end point of the study is the rate of death
Myocardial Infarction
Time frame: 30 days
The primary end point of the study is the rate of myocardial infarction
Myocardial Infarction
Time frame: 1 year
The primary end point of the study is the rate of myocardial infarction
Myocardial Infarction
Time frame: 5 years
The primary end point of the study is the rate of myocardial infarction
Stent Thrombosis
Time frame: 30 days
The primary end point of the study is the rate of stent thrombosis
Stent Thrombosis
Time frame: 1 year
The primary end point of the study is the rate of stent thrombosis
Stent Thrombosis
Time frame: 5 years
The primary end point of the study is the rate of stent thrombosis
Acute Kidney Injury
Time frame: 30 days
The primary end point of the study is the rate of acute kidney injury
Acute Kidney Injury
Time frame: 1 years
The primary end point of the study is the rate of acute kidney injury
Coronary Obstruction Requiring Intervention
Time frame: 30 days
The primary end point of the study is the rate of coronary obstruction requiring intervention
Coronary Obstruction Requiring Intervention
Time frame: 1 year
The primary end point of the study is the rate of coronary obstruction requiring intervention
Coronary Obstruction Requiring Intervention
Time frame: 5 years
The primary end point of the study is the rate of coronary obstruction requiring intervention
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
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
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)
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)
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)
4 secondary outcomes
Target Vessel Revascularization
Time frame: 1 year
Target Vessel Revascularization
Time frame: 5 years
Target Lesion Revascularization
Time frame: 1 year
Target Lesion Revascularization
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francesco Nappi, MD principal investigator
Centre Cardiologique du Nord
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Infarction (MI) and Radiation Toxicity, run by Centre Cardiologique du Nord at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death (time frame: 30 days). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026; AzTrials last refreshed its copy on 29 Oct 2026.