NCT05713201

Brief Summary

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

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2022

Typical duration for all trials

Geographic Reach
2 countries

8 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 6, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

April 18, 2023

Status Verified

April 1, 2023

Enrollment Period

1.4 years

First QC Date

January 23, 2023

Last Update Submit

April 14, 2023

Conditions

Keywords

PCIAcute Coronary SyndromeAneurysmatic Right Coronary Artery

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Target Lesion Failure

    12 moths

Study Arms (2)

Index PCI

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

Procedure: Percutaneous Coronary Intervention

Staged PCI

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

Procedure: Percutaneous Coronary Intervention

Interventions

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

Index PCIStaged PCI

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with aneurysmatic or ectatic right coronary artery disease in the acute setting following PCI.

You may qualify if:

  • 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).

You may not qualify if:

  • Elective aneurysmatic or ectasic RCA PCI
  • Patient with lack of accurate procedural and clinical data
  • Patient with lack of clinical or angiographic follow up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Ospedale Papa Giovanni XXIII

Bergamo, Italy

RECRUITING

Azienda Ospedaliera Brotzu

Cagliari, 09047, Italy

RECRUITING

Policlinico Universitario G.Rodolico

Catania, 95123, Italy

RECRUITING

Azienda Ospedaliera Universitaria Gaetano Martino

Messina, 98124, Italy

RECRUITING

Ospedale Auxologico San Luca

Milan, Italy

RECRUITING

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

Turin, 10100, Italy

RECRUITING

Ospedale Universitario Marqués de Valdecilla

Santander, Satander, 39008, Spain

RECRUITING

Hospital Clinico San Carlos

Madrid, Spain

RECRUITING

MeSH Terms

Conditions

Coronary DiseaseCoronary AneurysmST Elevation Myocardial InfarctionAcute Coronary Syndrome

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesAneurysmMyocardial InfarctionInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Endovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Central Study Contacts

Giulio Piedimonte, MD

CONTACT

Enrico Cerrato, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

January 23, 2023

First Posted

February 6, 2023

Study Start

November 1, 2022

Primary Completion

April 1, 2024

Study Completion

December 1, 2024

Last Updated

April 18, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations