Outcomes After PCI of the Aneurysmatic Right Coronary Artery

NCT ID: NCT05713201

Last Updated: 2023-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-01

Study Completion Date

2024-12-01

Brief Summary

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

Detailed Description

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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.

Conditions

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

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Index PCI

Patients with an aneurysmatic right coronary artery undergoing index PCI in the acute setting.

Percutaneous Coronary Intervention

Intervention Type PROCEDURE

Treatment of coronary stenoses with a drug-eluting stent or balloon

Staged PCI

Patients with an aneurysmatic right coronary artery undergoing staged PCI in the acute setting.

Percutaneous Coronary Intervention

Intervention Type PROCEDURE

Treatment of coronary stenoses with a drug-eluting stent or balloon

Interventions

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Percutaneous Coronary Intervention

Treatment of coronary stenoses with a drug-eluting stent or balloon

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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San Luigi Gonzaga Hospital

OTHER

Sponsor Role lead

Responsible Party

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Enrico Cerrato

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ospedale Papa Giovanni XXIII

Bergamo, , Italy

Site Status RECRUITING

Azienda Ospedaliera Brotzu

Cagliari, , Italy

Site Status RECRUITING

Policlinico Universitario G.Rodolico

Catania, , Italy

Site Status RECRUITING

Azienda Ospedaliera Universitaria Gaetano Martino

Messina, , Italy

Site Status RECRUITING

Ospedale Auxologico San Luca

Milan, , Italy

Site Status RECRUITING

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

Turin, , Italy

Site Status RECRUITING

Ospedale Universitario Marqués de Valdecilla

Santander, Satander, Spain

Site Status RECRUITING

Hospital Clinico San Carlos

Madrid, , Spain

Site Status RECRUITING

Countries

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Italy Spain

Central Contacts

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Giulio Piedimonte, MD

Role: CONTACT

+393201764900

Enrico Cerrato, MD

Role: CONTACT

+393479317104

Facility Contacts

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Irene Pescetelli, MD

Role: primary

Alberto Boi, MD

Role: primary

Alberto Boi, MD

Role: backup

+393470330120

Riccardo Mangione, MD

Role: primary

+393298734159

Giampiero Vizzari, MD

Role: primary

+39 (090) 221 2341

Dario Calderone, MD

Role: primary

Enrico Cerrato, MD

Role: primary

+390119026602

Jose Maria De La Torre Hernandez, MD

Role: primary

+34 942 20 25 20

Ivan Sanchez, MD,PhD

Role: primary

+34 91 330 30 00

Other Identifiers

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001-2022

Identifier Type: -

Identifier Source: org_study_id

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