Complete Revascularization Via Inferior Part-sternotomy

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorChina National Center for Cardiovascular Diseases

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Inferior part-sternotomy

    Procedure/Surgery

    A 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/Surgery

    A 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

260 Participants
are divided into 2 treatment groups
Group A: Inferior part-sternotomy CABGExperimental treatment 1 intervention
Group B: Full median sternotomy CABGActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Immediately after surgery

Secondary outcomes

1

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.

Time frame
During surgery
2

Aortic cross-clamp time

Time frame
During surgery
3

Overall operation time

It is defined as the time from skin incision to skin sutured.

Time frame
During surgery
4

Intraoperative real-time blood flow at each anastomosis

It was evaluated intraoperatively using ultrasound flow measurements.

Time frame
During surgery

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

This trial is not recruiting at the moment. You can still explore other options: