Complete Revascularization Via Inferior Part-sternotomy

Launched by CHINA NATIONAL CENTER FOR CARDIOVASCULAR DISEASES · Apr 27, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to perform heart surgery for patients with multiple blocked arteries, known as multivessel coronary artery disease. The study will compare two surgical methods: one that uses a smaller incision at the bottom of the breastbone (called inferior part-sternotomy) and another that uses a larger incision down the middle of the breastbone (full median sternotomy). The goal is to see if the smaller incision can provide the same benefits and safety as the traditional method while helping patients recover faster. The trial will involve around 260 patients from nine hospitals in China.

To be eligible for this trial, participants must be adults who need surgery for multiple blocked arteries but do not have single or double vessel disease. They should not have severe heart, kidney, or other systemic health issues, and must not be undergoing other types of heart surgery at the same time. If you choose to participate, you can expect to be randomly assigned to one of the two surgical methods, and the research team will closely monitor your recovery and outcomes. This trial is not yet recruiting participants, but it aims to gather important information about a potentially less invasive option for heart surgery.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients who undergo primary isolated open-chest CABG with multi-vessel coronary disease(left main artery disease with right coronary artery disease,or three-vessel disease)
• Exclusion Criteria:
• • 1. Single vessel disease, double vessel disease, left main artery disease without right coronary artery disease.
• • 2. Concomitant cardiac surgeries(i.e. valve repair or replacement, Maze surgery, left ventricular repair due to ventricular aneurysm).
• • 3. Redo CABG.
• • 4. Emergent CABG.
• • 5. Left ventricular ejection fraction(EF≤35%).
• • 6. Severe atherosclerosis of the ascending aorta.
• • 7. Subjects tend to choose surgical approach (via full median sternotomy/inferior part-sternotomy) .
• • 8. Malignant tumor or other severe systemic diseases.
• • 9. Severe renal insufficiency (i.e. creatinine \>200 μmol/L).
• • 10. Contraindications for dual antiplatelet therapy, such as active gastroduodenal ulcer.
• • 11. Participant of other ongoing clinical trials.