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

Sponsor
San Luigi Gonzaga Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05713201
Collaborator
(none)
90
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Study Details

Study Description

Brief Summary

This study aims to evaluate procedural and clinical outcomes of ACS patients with aneurysmatic culprit RCA.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Percutaneous Coronary Intervention

Detailed Description

The investigators sought differences in procedural (slow-flow, no-reflow, distal embolisation, TIMI final flow etc.) and in immediate and long-term clinical outcomes between several subgroups such as index vs staged PCI, premedication vs none, use of IIb/IIIa inhibitors vs none, BMS vs 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

Study Type:
Observational
Anticipated Enrollment :
90 participants
Observational Model:
Case-Only
Time Perspective:
Retrospective
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
Actual Study Start Date :
Nov 1, 2022
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
Jul 1, 2023

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Technical success [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)

Secondary Outcome Measures

  1. Target Lesion Failure [12 moths]

    Combination of cardiac death, target vessel MI and clinically target lesion revascularization

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ospedale Papa Giovanni XXIII Bergamo Italy
2 Azienda Ospedaliera Brotzu Cagliari Italy 09047
3 Policlinico Universitario G.Rodolico Catania Italy 95123
4 Azienda Ospedaliera Universitaria Gaetano Martino Messina Italy 98124
5 Ospedale Auxologico San Luca Milan Italy
6 Interventional Unit, San Luigi Gonzaga University Hospital, Orbassano, and Rivoli Hospital, Turin, Italy Turin Italy 10100
7 Ospedale Universitario Marqués de Valdecilla Santander Satander Spain 39008
8 Hospital Clinico San Carlos Madrid Spain

Sponsors and Collaborators

  • San Luigi Gonzaga Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Enrico Cerrato, Principal investigator, San Luigi Gonzaga Hospital
ClinicalTrials.gov Identifier:
NCT05713201
Other Study ID Numbers:
  • 001-2022
First Posted:
Feb 6, 2023
Last Update Posted:
Feb 6, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Enrico Cerrato, Principal investigator, San Luigi Gonzaga Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 6, 2023