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Clinical Trials/NCT05713201
NCT05713201
Recruiting
Not Applicable

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

San Luigi Gonzaga Hospital8 sites in 2 countries90 target enrollmentNovember 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Coronary Disease
Sponsor
San Luigi Gonzaga Hospital
Enrollment
90
Locations
8
Primary Endpoint
Technical success
Status
Recruiting
Last Updated
3 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
November 1, 2022
End Date
December 1, 2024
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
San Luigi Gonzaga Hospital
Responsible Party
Principal Investigator
Principal Investigator

Enrico Cerrato

Principal investigator

San Luigi Gonzaga Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

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)

Secondary Outcomes

  • Target Lesion Failure(12 moths)

Study Sites (8)

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