ClinicalTrials.gg
Status unknownNCT05713201RIGHT-MAREUpdated Apr 18, 2023

Outcomes After PCI of the Aneurysmatic Right Coronary Artery

An observational study in Coronary Disease, Coronary Artery Ectasia and Right Coronary Artery Occlusion, sponsored by San Luigi Gonzaga Hospital. Status unknown at 8 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-18.

Sponsored by San Luigi Gonzaga Hospital · Observational

The sponsor has not verified this record recently (last verified Apr 2023), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
90
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Coronary Disease
  • Coronary Artery Ectasia
  • Right Coronary Artery Occlusion
  • Right Coronary Artery Stenosis
  • STEMI

Keywords

  • PCI
  • Acute Coronary Syndrome
  • Aneurysmatic Right Coronary Artery
03

In context

Coronary Disease

1,520 studies on the registry are indexed under Coronary Disease; 167 are open to participants now.

This study's planned enrollment of 90 is below the median of 916 across 478 observational studies indexed under Coronary Disease.

Browse Coronary Disease studies →

Lead sponsor

San Luigi Gonzaga Hospital is the lead sponsor of 20 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
90 participants (estimated)
Patient registry
No

Groups and cohorts

  • Index PCI

    Patients with an aneurysmatic right coronary artery undergoing index PCI in the acute setting.

    Procedure: Percutaneous Coronary Intervention

  • Staged PCI

    Patients with an aneurysmatic right coronary artery undergoing staged PCI in the acute setting.

    Procedure: Percutaneous Coronary Intervention

Interventions

  • ProcedurePercutaneous Coronary Intervention

    Treatment of coronary stenoses with a drug-eluting stent or balloon

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: 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

    Time frame: 12 moths

07

Study locations

8 of 8 sites recruiting
  • Ospedale Papa Giovanni XXIII
    Bergamo, Italy
    Recruiting
  • Azienda Ospedaliera Brotzu
    Cagliari, 09047, Italy
    Recruiting
  • Policlinico Universitario G.Rodolico
    Catania, 95123, Italy
    Recruiting
  • Azienda Ospedaliera Universitaria Gaetano Martino
    Messina, 98124, Italy
    Recruiting
  • Ospedale Auxologico San Luca
    Milan, Italy
    Recruiting
  • Interventional Unit, San Luigi Gonzaga University Hospital, Orbassano, and Rivoli Hospital, Turin, Italy
    Turin, 10100, Italy
    Recruiting
  • Ospedale Universitario Marqués de Valdecilla
    Santander, Satander 39008, Spain
    Recruiting
  • Hospital Clinico San Carlos
    Madrid, Spain
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05713201
Lead sponsor
San Luigi Gonzaga Hospital
Responsible party
Enrico Cerrato (Principal investigator, San Luigi Gonzaga Hospital) — Principal investigator
First posted
Feb 6, 2023
Start date
Nov 1, 2022
Primary completion
Apr 1, 2024 (estimated)
Completion
Dec 1, 2024 (estimated)
Last update
Apr 18, 2023

Study contacts

Giulio Piedimonte, MD
Contact
giulio.piedimonte@gmail.com
+393201764900
Enrico Cerrato, MD
Contact
enrico.cerrato@gmail.com
+393479317104

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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