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

Beijing Anzhen Hospital320 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

320

Conditions

Coronary Atherosclerotic Heart Disease

Interventions

A method of operation: LIMA-GSV-SCVBGPROCEDURE

On the experimental group,We treat patients with the operation of LIMA-GSV composited Y graft and anastomose the GSV with selective coronary vein

BIMA-SCVBGPROCEDURE

On the other group, We treat patients with the operation of bilateral internal mammary artery composited LIMA-Right Mammary Artery（RIMA） y graft and anastomose the Right Mammary Artery(RIMA) with selective coronary vein.

Eligibility

Sex: ALLMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

Beijing An Zhen Hospital , Capital Medical University

Beijing, Beijing Municipality, China

RECRUITING

Outcomes

Primary Outcomes

The patency rate of bridge vessels and selective coronary vein

We will assess the patency rate during a follow-up of 1 year, and continue to follow up to 3 years after the end of the project

Time frame: 1-3 years

Secondary Outcomes

Main adverse cardiovascular and cerebrovascular events

We will follow up the main adverse cardiovascular and cerebrovascular events ( death, myocardial infarction, stroke and repeated revascularization) 7 days, 1 month, 3 months, 6 months and 1 year after the operation and continue to 3 years.

Time frame: 1-3 years

Wound complications

We will follow up the wound complications (sternum and mediastinal infection, incision infection, fat liquefaction) 7 days, 1 month, 3 months, 6 months and 1 year after the operation and continue to 3 years.

Time frame: 1-3 years

Data from ClinicalTrials.gov

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