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NCT06023355 Clinical Trial

Sex-related Differences in Outcome After Hybrid Coronary Revascularization

Coronary Artery Disease Clinical Trial

— SEX-HYBRID  

Official title:
Sex-related Differences in Outcome After Hybrid Coronary Revascularization Versus Coronary Artery Bypass Grafting in Multivessel Coronary Artery Disease: The SEX-HYBRID Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06023355
Other study ID # 2023/D/1066
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date January 1, 2024
Est. completion date December 31, 2024

Study information
Verified date November 2023
Source University of Roma La Sapienza
Contact Francesco Pelliccia
Phone +390633062615
Email f.pelliccia@mclink.it
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

Description:

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. Limited by their sample size, these individual studies may have been under-powered to detect a difference. 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 1000
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: Patients with coronary artery disease and indication to cardiac surgery Exclusion Criteria: Contraindications to cardiac surgery

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• HYBRID
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.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University of Roma La Sapienza

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of Overall Mortality All causes deaths Up to 1 year
Primary Incidence of Composite End-point Cardiac death, myocardial infarction, stroke, bleeding Up to 1 year
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