Back to resultsA Clinical Randomized Controlled Trial of the New Method of Selective Coronary Vein Bypass Graft (SCVBG)
Primary Purpose
Coronary Atherosclerotic Heart Disease
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
A method of operation: LIMA-GSV-SCVBG
BIMA-SCVBG
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Atherosclerotic Heart Disease
Eligibility Criteria
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.
Sites / Locations
- Beijing An Zhen Hospital , Capital Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
LIMA-GSV-SCVBG Group
BIMA-SCVBG Group
Arm 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.
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT03334110
First Posted
September 17, 2017
Last Updated
November 2, 2017
Sponsor
Beijing Anzhen Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03334110
Brief Title
A Clinical Randomized Controlled Trial of the New Method of Selective Coronary Vein Bypass Graft (SCVBG)
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 30, 2017 (Anticipated)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
September 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Anzhen Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Atherosclerotic Heart Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
320 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
LIMA-GSV-SCVBG Group
Arm Type
Experimental
Arm 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.
Arm Title
BIMA-SCVBG Group
Arm Type
Other
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
A method of operation: LIMA-GSV-SCVBG
Intervention Description
On the experimental group,We treat patients with the operation of LIMA-GSV composited Y graft and anastomose the GSV with selective coronary vein
Intervention Type
Procedure
Intervention Name(s)
BIMA-SCVBG
Intervention Description
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.
Primary Outcome Measure Information:
Title
The patency rate of bridge vessels and selective coronary vein
Description
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 Outcome Measure Information:
Title
Main adverse cardiovascular and cerebrovascular events
Description
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
Title
Wound complications
Description
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
10. Eligibility
Sex
All
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Beijing An Zhen Hospital , Capital Medical University
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
yang yu, doctor
Phone
13911534101
Email
15915901281629@163.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
A Clinical Randomized Controlled Trial of the New Method of Selective Coronary Vein Bypass Graft (SCVBG)
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