- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05713201
Outcomes After PCI of the Aneurysmatic Right Coronary Artery (RIGHT-MARE)
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
-
Bergamo, Italy
- Recruiting
- Ospedale Papa Giovanni XXIII
-
Cagliari, Italy, 09047
- Recruiting
- Azienda Ospedaliera Brotzu
-
Catania, Italy, 95123
- Recruiting
- Policlinico Universitario G.Rodolico
-
Messina, Italy, 98124
- Recruiting
- Azienda Ospedaliera Universitaria Gaetano Martino
-
Milan, Italy
- Recruiting
- Ospedale Auxologico San Luca
-
Turin, Italy, 10100
- Recruiting
- Interventional Unit, San Luigi Gonzaga University Hospital, Orbassano, and Rivoli Hospital, Turin, Italy
-
-
-
-
-
Madrid, Spain
- Recruiting
- Hospital Clinico San Carlos
-
-
Satander
-
Santander, Satander, Spain, 39008
- Recruiting
- Ospedale Universitario Marqués de Valdecilla
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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).
Exclusion Criteria:
- Elective aneurysmatic or ectasic RCA PCI
- Patient with lack of accurate procedural and clinical data
- Patient with lack of clinical or angiographic follow up
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Index PCI
Patients with an aneurysmatic right coronary artery undergoing index PCI in the acute setting.
|
Treatment of coronary stenoses with a drug-eluting stent or balloon
|
Staged PCI
Patients with an aneurysmatic right coronary artery undergoing staged PCI in the acute setting.
|
Treatment of coronary stenoses with a drug-eluting stent or balloon
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
Procedural (from the start to the end of the procedure)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Target Lesion Failure
Time Frame: 12 moths
|
Combination of cardiac death, target vessel MI and clinically target lesion revascularization
|
12 moths
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 001-2022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Coronary Disease
-
Peking Union Medical College HospitalNot yet recruitingCoronary Artery Disease | Inflammation | Coronary Artery Disease Progression | Coronary Artery Stenosis | Coronary Artery Restenosis | Inflammatory Disease | Inflammation VascularChina
-
Peking Union Medical College HospitalRecruitingCoronary Artery Disease | Inflammation | Coronary Artery Disease Progression | Coronary Artery Stenosis | Coronary Artery Restenosis | Inflammatory Disease | Inflammation VascularChina
-
Fundación EPICActive, not recruitingCoronary Artery Disease | Left Main Coronary Artery Disease | Left Main Coronary Artery Stenosis | Restenosis, CoronarySpain
-
Peking University Third HospitalCompletedCoronary Microvascular Dysfunction | Obstructive Coronary Heart DiseaseChina
-
Centro de estudios en Cardiologia IntervencionistaCompletedCoronary Heart Disease | Coronary RestenosisArgentina
-
Seung-Jung ParkCardioVascular Research Foundation, KoreaRecruitingCoronary Stenosis | Coronary Artery Bypass Grafting | Coronary Artery Disease Progression | Percutaneous Coronary RevascularizationKorea, Republic of
-
Istanbul UniversityCompletedIschemic Heart Disease | Coronary Microvascular Disease | Microvascular Angina | Coronary Microvascular Dysfunction | Non-Obstructive Coronary Atherosclerosis | Microvascular Coronary Artery DiseaseTurkey
-
Deutsches Herzzentrum MuenchenCompletedCoronary Heart DiseaseGermany
-
National Institutes of Health Clinical Center (CC)National Heart, Lung, and Blood Institute (NHLBI)CompletedCoronary Arteriosclerosis | Coronary Artery Disease (CAD) | Obstructive Coronary Artery DiseaseUnited States
-
National Heart Centre SingaporeUnknownCoronary Heart DiseaseSingapore
Clinical Trials on Percutaneous Coronary Intervention
-
Mid and South Essex NHS Foundation TrustImperial College LondonRecruitingStable Angina | Chronic Total Occlusion of Coronary ArteryUnited Kingdom
-
University Hospital, SaarlandCompletedAcute Myocardial InfarctionGermany
-
Nanjing First Hospital, Nanjing Medical UniversityCompletedCoronary Artery DiseaseChina
-
University Hospital of PatrasCompletedCoronary Artery Bypass SurgeryGreece
-
Yonsei UniversityUnknownCoronary Artery Disease | Stable Angina | Unstable AnginaKorea, Republic of
-
ECRI bvBoston Scientific Corporation; Philips HealthcareActive, not recruitingLeft Main Coronary Artery StenosisSpain, United Kingdom, Italy
-
Herlev and Gentofte HospitalUnknownCoronary Heart Disease | Ischemic Heart Disease | Stable AnginaDenmark
-
RobocathCompletedCoronary Artery Disease | Percutaneous Coronary InterventionFrance, Belgium, Luxembourg, Netherlands
-
University College, LondonNational Institute for Cardiovascular Outcomes Research; British Cardiovascular... and other collaboratorsCompletedPercutaneous Coronary InterventionUnited Kingdom
-
Niels Ramsing HolmJohnson & JohnsonUnknown