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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05713201
Other study ID # 001-2022
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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

Study Design


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
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