Outcomes After PCI of the Aneurysmatic Right Coronary Artery

Recruiting

• Conditions: Right Coronary Artery Stenosis; Coronary Disease; Right Coronary Artery Occlusion; Coronary Artery Ectasia; STEMI
• Interventions: Procedure: Percutaneous Coronary Intervention

• Registration Number: NCT05713201
• Lead Sponsor: San Luigi Gonzaga Hospital

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.

Study Timeline

• Study Start: 2022-11-01
• Study First Submitted: 2023-01-23
• Study First Submitted QC: 2023-02-01
• Study First Posted: 2023-02-06
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-14
• Last Update Posted: 2023-04-18
• Primary Completion: 2024-04-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Index PCI	Percutaneous Coronary Intervention	Patients with an aneurysmatic right coronary artery undergoing index PCI in the acute setting.
Staged PCI	Percutaneous Coronary Intervention	Patients with an aneurysmatic right coronary artery undergoing staged PCI in the acute setting.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Target Lesion Failure	12 moths	Combination of cardiac death, target vessel MI and clinically target lesion revascularization

Trial Locations

Locations (8)

Ospedale Papa Giovanni XXIII; 🇮🇹 Bergamo, Italy

Azienda Ospedaliera Brotzu; 🇮🇹 Cagliari, Italy

Ospedale Auxologico San Luca; 🇮🇹 Milan, Italy

Azienda Ospedaliera Universitaria Gaetano Martino; 🇮🇹 Messina, Italy

Policlinico Universitario G.Rodolico; 🇮🇹 Catania, Italy

Ospedale Universitario Marqués de Valdecilla; 🇪🇸 Santander, Satander, Spain

Hospital Clinico San Carlos; 🇪🇸 Madrid, Spain

Interventional Unit, San Luigi Gonzaga University Hospital, Orbassano, and Rivoli Hospital, Turin, Italy; 🇮🇹 Turin, Italy