Status:
ENROLLING_BY_INVITATION
MInithoraCotomy vs Sternotomy for Multivessel Coronary Artery Bypass Grafting: A Partially Randomized Patient Preference Trial Assessing Quality of Life and Patency Outcomes
Lead Sponsor:
Peking University Third Hospital
Conditions:
Coronary Artery Bypass, Off-Pump
Minimally Invasive Cardiac Surgery
Eligibility:
All Genders
25-85 years
Phase:
NA
Brief 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 patient...
Detailed Description
Objective and Hypothesis: The aim of this study is to investigate and compare the mid-term safety and efficacy end-points (SF-36 PCS at 30 days after surgery, etc.) in patients with complex coronary a...
Eligibility Criteria
Inclusion
- (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
- 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
Key Trial Info
Start Date :
April 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
248 Patients enrolled
Trial Details
Trial ID
NCT04795193
Start Date
April 15 2021
End Date
December 31 2025
Last Update
September 16 2025
Active Locations (1)
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1
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100191