About this trial
To verify the effectiveness and safety of minimally invasive coronary artery bypass grafting for complete revascularization of multivessel coronary artery disease via inferior part-sternotomy, We aim to randomize 260 patients undergoing isolated Coronary artery bypass grafting (CABG) to compare the ratios of complete revascularization between inferior part-sternotomy CABG and full median sternotomy CABG from 9 hospitals in China.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Single vessel disease, double vessel disease, left main artery disease without right coronary artery disease.
Concomitant cardiac surgeries(i.e. valve repair or replacement, Maze surgery, left ventricular repair due to ventricular aneurysm).
Redo CABG.
Emergent CABG.
Trial design
Parallel
Treatments tested in this trial
Inferior part-sternotomy
Procedure/SurgeryA midline skin incision of 8 to 10cm in length is made over the sternum, starting from 2-3cm below the sternal angle inferiorly and extending slightly beyond the xiphoid process. A sternal saw is used to split the sternum from the xiphoid process to the second intercostal space where the sternum is partially transected by turning the saw rightward.
Full median sternotomy
Procedure/SurgeryA midline skin incision is made over the sternum, starting from the sternal angle and extending slightly beyond the xiphoid process. The sternum is fully split by a sternal saw.
Treatment groups
Trial outcomes
Primary outcomes
Complete revascularization rate immediately after surgery
Most surgical groups have adopted the functional definition in their studies. We therefore elected to use a functional definition for complete revascularization in the present study. The coronary vascular tree was divided into 3 separate territories: the left anterior descending artery (LAD), the circumflex artery, and the right coronary artery (RCA).Functional completeness of revascularization is defined as all viable myocardial territories are reperfused, as at least one bypass graft for every diseased primary arterial territory
Secondary outcomes
The harvest time of left Internal mammary artery (LIMA)
It is defined as the time from skin incision to clamping of the distal part of the LIMA.
Aortic cross-clamp time
Overall operation time
It is defined as the time from skin incision to skin sutured.
Intraoperative real-time blood flow at each anastomosis
It was evaluated intraoperatively using ultrasound flow measurements.
Locations
Sponsors and contacts
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China National Center for Cardiovascular Diseases
Lead sponsor
Tangshan Central Hospital
Collaborator
Baotou Central Hospital
Collaborator
Xiamen Second Hospital
Collaborator
Beijing Shijitan Hospital, Capital Medical University
Collaborator
Peking University International Hospital
Collaborator
Shenzhen Sun Yat-sen Cardiovascular Hospital
Collaborator
Fuwai Yunnan Cardiovascular Hospital
Collaborator
Henan Provincial People's Hospital
Collaborator
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