Outcomes After PCI of the Aneurysmatic Right Coronary Artery

Coronary Disease Clinical Trial

— RIGHT-MARE  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05713201
• Other study ID #: 001-2022
• Status: Recruiting
• Start date: November 1, 2022
• Est. completion date: December 1, 2024

Study information

• Verified date: April 2023
• Source: San Luigi Gonzaga Hospital
• Contact: Giulio Piedimonte, MD
• Phone: +393201764900
• Email: giulio.piedimonte[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aims to evaluate procedural and clinical outcomes of acute coronay syndrome (ACS) patients with aneurysmatic culprit right coronary artery (RCA).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 1, 2024
• Est. primary completion date: April 1, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Percutaneous Coronary Intervention
Treatment of coronary stenoses with a drug-eluting stent or balloon

Locations

Country	Name	City	State
Italy	Ospedale Papa Giovanni XXIII	Bergamo
Italy	Azienda Ospedaliera Brotzu	Cagliari
Italy	Policlinico Universitario G.Rodolico	Catania
Italy	Azienda Ospedaliera Universitaria Gaetano Martino	Messina
Italy	Ospedale Auxologico San Luca	Milan
Italy	Interventional Unit, San Luigi Gonzaga University Hospital, Orbassano, and Rivoli Hospital, Turin, Italy	Turin
Spain	Hospital Clinico San Carlos	Madrid
Spain	Ospedale Universitario Marqués de Valdecilla	Santander	Satander

Sponsors (1)

Lead Sponsor	Collaborator
San Luigi Gonzaga Hospital

Countries where clinical trial is conducted

Italy,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Procedural (from the start to the end of the procedure)
Secondary	Target Lesion Failure	Combination of cardiac death, target vessel MI and clinically target lesion revascularization	12 moths