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

Not Applicable

• Conditions: Coronary Atherosclerotic Heart Disease
• Interventions: Procedure: BIMA-SCVBG

• Registration Number: NCT03334110
• Lead Sponsor: Beijing Anzhen Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-09-17
• Status Verified: 2017-11
• Study First Submitted QC: 2017-11-02
• Last Update Submitted: 2017-11-02
• Study First Posted: 2017-11-07
• Last Update Posted: 2017-11-07
• Study Start: 2017-11-30
• Primary Completion: 2017-12
• Study Completion: 2018-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 320

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BIMA-SCVBG Group	BIMA-SCVBG	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.

Primary Outcome Measures

Name	Time	Method
The patency rate of bridge vessels and selective coronary vein	1-3 years	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

Secondary Outcome Measures

Name	Time	Method
Main adverse cardiovascular and cerebrovascular events	1-3 years	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.
Wound complications	1-3 years	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.

Trial Locations

Locations (1)

Beijing An Zhen Hospital , Capital Medical University; 🇨🇳 Beijing, Beijing, China