Outcomes After PCI of the Aneurysmatic Right Coronary Artery (RIGHT-MARE)

April 14, 2023 updated by: Enrico Cerrato, San Luigi Gonzaga Hospital

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).

Study Overview

Status

Recruiting

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

Observational

Enrollment (Anticipated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • 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
  • Spain
      • Madrid, Spain
        • Recruiting
        • Hospital Clinico San Carlos
    • Satander
      • Santander, Satander, Spain, 39008
        • Recruiting
        • Ospedale Universitario Marqués de Valdecilla

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients with aneurysmatic or ectatic right coronary artery disease in the acute setting following PCI.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
Procedure: Percutaneous Coronary Intervention
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.
Procedure: Percutaneous Coronary Intervention
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

This is where you will find people and organizations involved with this study.

Sponsor

San Luigi Gonzaga Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2022

Primary Completion (Anticipated)

April 1, 2024

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

January 23, 2023

First Submitted That Met QC Criteria

February 1, 2023

First Posted (Actual)

February 6, 2023

Study Record Updates

Last Update Posted (Actual)

April 18, 2023

Last Update Submitted That Met QC Criteria

April 14, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 001-2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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