A Clinical Randomized Controlled Trial of the New Method of Selective Coronary Vein Bypass Graft (SCVBG)

Capital Medical University

Status: Unknown

Conditions: Coronary Atherosclerotic Heart Disease

Treatments: Procedure: A method of operation: LIMA-GSV-SCVBG; Procedure: BIMA-SCVBG

Study type: Interventional

Funder types: Other

Identifiers

NCT03334110

Z151100004015177

Details and patient eligibility

About

Apply a new operation method of Left Internal Mammary Artery (LIMA)-Greater Saphenous Vein (GSV)-SCVBG to the treatment of patients with diffuse coronary artery disease,through clinical randomized controlled study,compared with patients of bilateral internal mammary artery (BIMA)-SCVBG and evaluate both of therapeutic effects and prognosis.

Enrollment: 320 estimated patients

Sex: All

Ages: Under 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with right coronary artery diffuse lesions:Right coronary artery lumen≤1mm，Lesion lengths ≥20mm or multiple segment lesions.
• Patients of coronary artery bypass grafting (CABG) that can't be treated through endarterectomy.
• Patients ≤ 70 years old.
• All enrolled patients must being signed the informed consent.

Exclusion criteria

• Severe heart failure(ejection fraction under 35%) or non coronary atherosclerotic heart disease patients such as combined with severe valvular heart disease.
• Patients with acute myocardial infarction.
• Assistant examinations indicate that the bridge vessels can't be used；The left subclavian artery stenosis and/or LIMA lesions；RIMA lesions；varicosis of both great saphenous vein.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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320 participants in 2 patient groups

LIMA-GSV-SCVBG Group

Experimental group

Description:

Experimental group: The intervention：we apply a new operation on the patients with diffuse coronary artery disease(DCAD), we choose LIMA-GSV composited Y graft and anastomose the GSV with selective coronary vein.

Treatment:

Procedure: A method of operation: LIMA-GSV-SCVBG

BIMA-SCVBG Group

Other group

Description:

The other group：The intervention: We choose bilateral internal mammary artery composited LIMA-Right Mammary Internal Artery（RIMA） y graft， and anastomose the RIMA with selective coronary vein.

Treatment:

Procedure: BIMA-SCVBG