NCT06023355

Brief Summary

Hybrid coronary revascularization (HCR) has emerged as a favorable technique over traditional coronary artery bypass grafting (CABG) in a select group of patients with multivessel coronary artery disease (CAD). Till date, multiple individual studies comparing HCR with CABG have been carried out, but no data on the potential impact of sex on the outcome of HCR exist. To fill this knowledge gap, the investigators aim to perform an international collaborative multi-center study in order to examine gender differences in short-term and long-term outcomes among patients who underwent HCR or CABG.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2024

Shorter than P25 for all trials

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 28, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 5, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

November 29, 2023

Status Verified

November 1, 2023

Enrollment Period

1 year

First QC Date

August 28, 2023

Last Update Submit

November 27, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Incidence of Overall Mortality

    All causes deaths

    Up to 1 year

  • Incidence of Composite End-point

    Cardiac death, myocardial infarction, stroke, bleeding

    Up to 1 year

Interventions

HYBRIDPROCEDURE

It involves the combination of a sternal sparing left internal mammary artery (LIMA) bypass and percutaneous coronary intervention (PCI) with drug-eluting stents (DES) for non-left anterior descending (LAD) lesions. Through minimally invasive surgical techniques, HCR carries the potential for faster recovery postoperatively, fewer in-hospital complications, and lower utilization of healthcare resources, while providing the key benefits of LIMA-LAD grafting.

Eligibility Criteria

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

Patients with multivessel coronary artery disease and indication to cardiac surgery

You may qualify if:

  • Patients with coronary artery disease and indication to cardiac surgery

You may not qualify if:

  • Contraindications to cardiac surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Central Study Contacts

Francesco Pelliccia

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 28, 2023

First Posted

September 5, 2023

Study Start

January 1, 2024

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

November 29, 2023

Record last verified: 2023-11