Coronary DiseaseRIGHT-MARENCT05713201
Outcomes After PCI of the Aneurysmatic Right Coronary Artery
An observational study of Coronary Disease and Coronary Artery Ectasia, run by San Luigi Gonzaga Hospital at 8 sites in 2 countries.
Trial summary
This study aims to evaluate procedural and clinical outcomes of acute coronay syndrome (ACS) patients with aneurysmatic culprit right coronary artery (RCA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Disease, Coronary Artery Ectasia, Right Coronary Artery Occlusion
- What is being tested?
- Percutaneous Coronary Intervention
- Type of treatment
- Surgery or procedure
- How many people
- 90 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 1 Nov 2022to 1 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Adult, Older adult
Study population: Patients with aneurysmatic or ectatic right coronary artery disease in the acute setting following PCI.
Who may be able to join
- Patients with ACS of the aneurysmatic or ectasic RCA
- Patient with at least 6 months clinical or angiographic follow-up
- Patients with accurate procedural and clinical records (particularly use of drugs before, during and after procedure, according to RCA PCI procedure (index or staged).
Who cannot join
- Elective aneurysmatic or ectasic RCA PCI
- Patient with lack of accurate procedural and clinical data
- Patient with lack of clinical or angiographic follow up
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
Italy6 sites, 6 recruiting
- Recruiting
Ospedale Papa Giovanni XXIII
Bergamo
Irene Pescetelli, MD, irene.pescetelli@gmail.com
- Recruiting
Azienda Ospedaliera Brotzu
Cagliari, 09047
Alberto Boi, MD, dott.albertoboi@gmail.com
Alberto Boi, MD, +393470330120, dott.albertoboi@gmail.com
- Recruiting
Policlinico Universitario G.Rodolico
Catania, 95123
Riccardo Mangione, MD, +393298734159, riccardomangione@icloud.com
- Recruiting
Azienda Ospedaliera Universitaria Gaetano Martino
Messina, 98124
Giampiero Vizzari, MD, +39 (090) 221 2341, GIAMPIEROVIZZARI@HOTMAIL.IT
- Recruiting
Ospedale Auxologico San Luca
Milan
Dario Calderone, MD, "Vandario@hotmail.it
- Recruiting
Interventional Unit, San Luigi Gonzaga University Hospital, Orbassano, and Rivoli Hospital, Turin, Italy
Turin, 10100
Enrico Cerrato, MD, +390119026602, enrico.cerrato@gmail.com
Enrico Cerrato, MD
Spain2 sites, 2 recruiting
- Recruiting
Hospital Clinico San Carlos
Madrid
Ivan Sanchez, MD,PhD, +34 91 330 30 00, sanchezsanchezivanmed@gmail.com
Ivan Sanchez, MD, PhD
- Recruiting
Ospedale Universitario Marqués de Valdecilla
Santander, Satander, 39008
Jose Maria De La Torre Hernandez, MD, +34 942 20 25 20, josemariadela.torre@scsalud.es
About this study
Official title: Percutaneous Coronary Interventions of the Aneurysmatic and Ectasic Right Coronary Artery in the Acute Setting: Management and Immediate- and Long-Term Outcomes The RIGHT-MARE Study
This study aims to evaluate procedural and clinical outcomes of acute coronay syndrome (ACS) patients with aneurysmatic culprit right coronary artery (RCA).
Read the detailed description
The investigators sought differences in procedural (slow-flow, no-reflow, distal embolisation,Thrombolysis in Myocardial Infarction final flow (TIMI) etc.) and in immediate and long-term clinical outcomes between several subgroups such as index vs staged percutaneous coronary intervention (PCI), premedication vs none, use of IIb/IIIa inhibitors vs none, bare metal stent (BMS) vs drug eluting stent (DES), ultrathin DES vs thick DES, durable polymer vs bioresorbable or free polymer etc.
The investigators also want to investigate the efficacy of different technical manoeuvres involved in resolving high thrombotic burden before stent deployment, such as thrombus aspiration, dilatation, intracoronary infusion of adenosine or thrombolytic agents, direct stenting etc.). Long-term follow-up includes target vessel failure (Cardiac Death, target vessel MI, clinically-driven target vessel revascularisation), define or probable stent thrombosis, target vessel revascularisation for ACS, clinically driven target vessel revascularisation and intrastent restenosis.
- Conditions
- Coronary Disease, Coronary Artery Ectasia, Right Coronary Artery Occlusion, Right Coronary Artery Stenosis, STEMI
- Being tested
- Percutaneous Coronary Intervention
- Keywords
- PCI, Acute Coronary Syndrome, Aneurysmatic Right Coronary Artery
- Medical subject headings
- Coronary Disease, Coronary Aneurysm, ST Elevation Myocardial Infarction, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Coronary InterventionProcedure or surgery
Treatment of coronary stenoses with a drug-eluting stent or balloon
| Study group | Role | What they receive |
|---|---|---|
| Index PCI | Patients with an aneurysmatic right coronary artery undergoing index PCI in the acute setting. Receives: Procedure: Percutaneous Coronary Intervention | |
| Staged PCI | Patients with an aneurysmatic right coronary artery undergoing staged PCI in the acute setting. Receives: Procedure: Percutaneous Coronary Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical success
Defined as final TIMI flow > 3 (TIMI 0: absence of any integrate flow beyond the coronary occlusion; TIMI 1: faint antegrade flow beyond the coronary occlusion with incomplete filling of the distal coronary bed; TIMI 2: delayed flow beyond the coronary occlusion with complete filling of the distal coronary bed; TIMI 3: normal flow with complete filling of the distal coronary bed)
Measured: Procedural (from the start to the end of the procedure)
Secondary outcomes (1)
Target Lesion Failure
Combination of cardiac death, target vessel MI and clinically target lesion revascularization
Measured: 12 moths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study start1 Nov 2022
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary DiseaseStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- San Luigi Gonzaga Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enrico Cerrato, San Luigi Gonzaga Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05713201
- Sponsor's protocol ID
- 001-2022
- Acronym
- RIGHT-MARE
- Status last verified
- Apr 2023
- First submitted
- 23 Jan 2023
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Piedimonte G, Cerrato E, Rolfo C, Nunez Gil IJ, Azzalini L, Mangione R, Maiellaro F, Boi A, Riganelli D, Sardone A, Bruno F, Scudiero F, Vizzari G, Carciotto G, Calderone D, Borgi M, Cancro FP, Sanchez I, Leoncini M, Sagazio E, Colombo F, Rosso G, Chechi T, Zecchino S, Pavani M, Franze A, Zanda G, Bosco M, Hernandez JMT, Micari A, Galasso G, Versaci F, Tamburino C, Patti G, La Manna A, Tomassini F, Varbella F. Percutaneous coronary interventions for aneurysmatic right coronary artery in acute coronary syndrome: RIGHTMARE registry outcomes. Cardiovasc Revasc Med. 2025 Jun;75:71-79. doi: 10.1016/j.carrev.2024.08.013. Epub 2024 Aug 22.
PubMed 39181812
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Coronary Interventions of the Aneurysmatic and Ectasic Right Coronary Artery in the Acute Setting: Management and Immediate- and Long-Term Outcomes The RIGHT-MARE Study
- ClinicalTrials.gov ID
- NCT05713201
- Acronym / sponsor ID
- RIGHT-MARE / 001-2022
- Conditions
- Coronary Disease, Coronary Artery Ectasia, Right Coronary Artery Occlusion, Right Coronary Artery Stenosis, STEMI
- Keywords
- PCI, Acute Coronary Syndrome, Aneurysmatic Right Coronary Artery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- San Luigi Gonzaga HospitalUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 6 Feb 2023 (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.
This study aims to evaluate procedural and clinical outcomes of acute coronay syndrome (ACS) patients with aneurysmatic culprit right coronary artery (RCA).
Detailed description
The investigators sought differences in procedural (slow-flow, no-reflow, distal embolisation,Thrombolysis in Myocardial Infarction final flow (TIMI) etc.) and in immediate and long-term clinical outcomes between several subgroups such as index vs staged percutaneous coronary intervention (PCI), premedication vs none, use of IIb/IIIa inhibitors vs none, bare metal stent (BMS) vs drug eluting stent (DES), ultrathin DES vs thick DES, durable polymer vs bioresorbable or free polymer etc.
The investigators also want to investigate the efficacy of different technical manoeuvres involved in resolving high thrombotic burden before stent deployment, such as thrombus aspiration, dilatation, intracoronary infusion of adenosine or thrombolytic agents, direct stenting etc.). Long-term follow-up includes target vessel failure (Cardiac Death, target vessel MI, clinically-driven target vessel revascularisation), define or probable stent thrombosis, target vessel revascularisation for ACS, clinically driven target vessel revascularisation and intrastent restenosis.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Index PCI | – | Procedure: Percutaneous Coronary InterventionPatients with an aneurysmatic right coronary artery undergoing index PCI in the acute setting. |
| Staged PCI | – | Procedure: Percutaneous Coronary InterventionPatients with an aneurysmatic right coronary artery undergoing staged PCI in the acute setting. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with aneurysmatic or ectatic right coronary artery disease in the acute setting following PCI.
Key inclusion criteria (3 listed)
- Patients with ACS of the aneurysmatic or ectasic RCA
- Patient with at least 6 months clinical or angiographic follow-up
- Patients with accurate procedural and clinical records (particularly use of drugs before, during and after procedure, according to RCA PCI procedure (index or staged).
Key exclusion criteria (3 listed)
- Elective aneurysmatic or ectasic RCA PCI
- Patient with lack of accurate procedural and clinical data
- Patient with lack of clinical or angiographic follow up
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 |
|---|---|---|
| Percutaneous Coronary InterventionTreatment of coronary stenoses with a drug-eluting stent or balloon | Procedure or surgery | Index PCI, Staged PCI |
Primary outcome
Technical success
Time frame: Procedural (from the start to the end of the procedure)
Defined as final TIMI flow > 3 (TIMI 0: absence of any integrate flow beyond the coronary occlusion; TIMI 1: faint antegrade flow beyond the coronary occlusion with incomplete filling of the distal coronary bed; TIMI 2: delayed flow beyond the coronary occlusion with complete filling of the distal coronary bed; TIMI 3: normal flow with complete filling of the distal coronary bed)
1 secondary outcome
Target Lesion Failure
Time frame: 12 moths
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Derived from this study: PubMed 39181812Piedimonte G, Cerrato E, Rolfo C, Nunez Gil IJ, Azzalini L, Mangione R, Maiellaro F, Boi A, Riganelli D, Sardone A, Bruno F, Scudiero F, Vizzari G, Carciotto G, Calderone D, Borgi M, Cancro FP, Sanchez I, Leoncini M, Sagazio E, Colombo F, Rosso G, Chechi T, Zecchino S, Pavani M, Franze A, Zanda G, Bosco M, Hernandez JMT, Micari A, Galasso G, Versaci F, Tamburino C, Patti G, La Manna A, Tomassini F, Varbella F. Percutaneous coronary interventions for aneurysmatic right coronary artery in acute coronary syndrome: RIGHTMARE registry outcomes. Cardiovasc Revasc Med. 2025 Jun;75:71-79. doi: 10.1016/j.carrev.2024.08.013. Epub 2024 Aug 22.
- 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.
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Disease and Coronary Artery Ectasia, run by San Luigi Gonzaga Hospital at 8 sites in 2 countries.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Italy, Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Giulio Piedimonte, MD (+393201764900, giulio.piedimonte@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical success (time frame: Procedural (from the start to the end of the procedure)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05713201, which also lists 1 linked publication.
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 18 Apr 2023.