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

Coronary Atherosclerotic Heart Disease Clinical Trial

Official title:

Clinical Randomized Controlled Trial of the New Method of Selective Coronary Venous Bypass Graft on Improving Curative Effects in Patients With Diffuse Coronary Artery Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03334110
• Other study ID #: Z151100004015177
• Status: Recruiting
• Phase: N/A
• First received: September 17, 2017
• Last updated: November 2, 2017
• Start date: November 30, 2017
• Est. completion date: September 2018

Study information

• Verified date: November 2017
• Source: Beijing Anzhen Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 320
• Est. completion date: September 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Atherosclerotic Heart Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

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

Locations

Country	Name	City	State
China	Beijing An Zhen Hospital , Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Anzhen Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1-3 years
Secondary	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.	1-3 years
Secondary	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.	1-3 years