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ENROLLING BY INVITATION

NCT04795193

MInithoraCotomy vs Sternotomy for Multivessel Coronary Artery Bypass Grafting: A Partially Randomized Patient Preference Trial Assessing Quality of Life and Patency Outcomes

Sponsor: Peking University Third Hospital

View on ClinicalTrials.gov

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 (1 month) after surgery and the overall patency rate of the grafts within 14 days ( before discharge) 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.

Official title: A Partially Randomized Patient Preference Trial to Assess the Quality of Life and Patency Rate After Minimally Invasive Cardiac Surgery-Coronary Artery Bypass Grafting: the MICS-CABG PRPP Trial

Key Details

Gender

All

Age Range

25 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

248

Start Date

2021-04-15

Completion Date

2025-12-31

Last Updated

2025-09-16

Healthy Volunteers

Conditions

Coronary Artery Bypass, Off-Pump Minimally Invasive Cardiac Surgery

Interventions

PROCEDURE

Minimal invasive coronary surgery

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

PROCEDURE

Off-pump coronary artery bypass surgery

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

Inclusion Criteria:(A patient will be included in the study when the following criteria and requirements are met) ① Patient age of ≥25 years but ≤85 years, and patients with CAD who require multivessel coronary bypass surgery. ② Angina that affects daily life and work and is uncontrollable with conservative treatment. ③ Significant stenosis in the left main (LM) coronary artery, left anterior descending (LAD) branch or left circumflex (LCX) branch \>70%. ④ Severe stenosis (stenosis degree \>70%) of three main branches of the coronary artery (anterior descending branch, circumflex branch, right coronary artery) with the need to undergo off-pump coronary artery bypass surgery. Exclusion Criteria: * Unstable preoperative hemodynamic status requiring emergency surgery * Severe emphysema, hypoxemia \[post-bronchodilator forced expiratory volume in 1 s (FEV1)/forced vital capacity (FVC)\<70% and FEV1%predicted\<50% or partial pressure of oxygen (pO2)\<60 mmHg or partial pressure of carbon dioxide (pCO2)\>40 mmHg without oxygen therapy\] * Old large area myocardial infarction, no viable myocardium based on isotope and echocardiography examination, significant cardiac enlargement, cardiothoracic ratio\>0.75, EF\<30%, left ventricular diastolic diameter (LVDd)\>60 mm, left ventricular aneurysm or severe arrhythmia, prone to experience unstable preoperative hemodynamic status during surgery * Severe pleural adhesion, chest deformity, or previous thoracic radiotherapy * Previous open heart surgery * Simultaneous valve or other cardiac surgery * Planned cardiopulmonary bypass surgery * Poor condition of myocardial infarction (MI), extensive lesion, distal or entire diffuse stenosis, or inability to match lumen due to small diameter (\<1.0 mm) or severe calcification * Others: Terminal cancer, uncontrolled infection, bleeding, progressive degenerative systemic disease, severe brain injury, multiple organ failure and other major organ dysfunction such as severe liver dysfunction, severe heart failure or cardiogenic shock, intolerance to surgery, and other contraindications of CABG

Locations (1)

Peking University Third Hospital

Beijing, Beijing Municipality, China