Clinical trial NCT05713201: Outcomes After PCI of the Aneurysmatic Right Coronary Artery
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Disease
Coronary Artery Ectasia
Right Coronary Artery Occlusion
Right Coronary Artery Stenosis
STEMI
Keywords: PCI
Acute Coronary Syndrome
Aneurysmatic Right Coronary Artery
Lead sponsor: San Luigi Gonzaga Hospital
Sponsor class: OTHER
First posted: 2023-02-06
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with aneurysmatic or ectatic right coronary artery disease in the acute setting following PCI.

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.

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

Primary outcomes:
measure: Technical success
timeFrame: Procedural (from the start to the end of the procedure)
Secondary outcomes:
measure: Target Lesion Failure
timeFrame: 12 moths
Other outcomes:
Locations:
city: Bergamo
country: Italy
facility: Ospedale Papa Giovanni XXIII
city: Cagliari
country: Italy
facility: Azienda Ospedaliera Brotzu
city: Catania
country: Italy
facility: Policlinico Universitario G.Rodolico
city: Messina
country: Italy
facility: Azienda Ospedaliera Universitaria Gaetano Martino
city: Milan
country: Italy
facility: Ospedale Auxologico San Luca
city: Turin
country: Italy
facility: Interventional Unit, San Luigi Gonzaga University Hospital, Orbassano, and Rivoli Hospital, Turin, Italy
city: Santander
country: Spain
facility: Ospedale Universitario Marqués de Valdecilla
state: Satander
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
Study officials:
References: