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The Quality of Life and Patency Rate After Minimally Invasive Cardiac Surgery

NCT05104320 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 248

Last updated 2021-11-02

No results posted yet for this study

Summary

This trial will address essential questions of the efficacy and safety of MICS-CABG in addition to the quality of life and patency rate of the grafts. The study will also address the impact of patients' preferences on external validity and internal validity.

In this study, patients with a preference will be allocated to treatment strategies accordingly, whereas only those patients without a distinct preference will be randomized. The randomized trial is a 248-patient controlled, randomized, investigator-blinded trial. It is designed to compare whether treatment with MICS-CABG is beneficial in comparison to CABG. This study is aimed to establish the superiority hypothesis for the physical component summary (PCS) accompanied by the noninferiority hypothesis for overall graft patency. Patients with no treatment preference will be randomized in a 1:1 fashion to one of the two treatment arms.

The primary efficacy endpoints are the PCS score at 30 days after surgery and the overall patency rate of the grafts within 14 days after surgery. Secondary outcome measures include the PCS score and patency rate at different time points. Safety endpoints include major adverse cardiac and cerebrovascular events, complications, bleeding, wound infection, death, etc.

Conditions

  • Minimally Invasive Cardiac Surgery

Interventions

PROCEDURE

MICS-CABG

Off-pump multi-vessel coronary artery bypass grafting via left thoracotomy under minimally invasive conditions.

PROCEDURE

sternotomy CABG

Off-pump multi-vessel coronary artery bypass grafting with conventional thoracotomy.

Sponsors & Collaborators

  • Peking University Third Hospital

    lead OTHER

Principal Investigators

  • Yunpeng Ling · Peking University Third Hospital

  • Yichen Gong · Peking University Third Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-31
Primary Completion
2024-10-31
Completion
2024-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05104320 on ClinicalTrials.gov