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

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ClinicalTrials.gov Identifier: NCT03334110
Recruitment Status : Unknown
Verified November 2017 by Yang Yu, Beijing Anzhen Hospital.
Recruitment status was:  Recruiting
First Posted : November 7, 2017
Last Update Posted : November 7, 2017
Sponsor:
Information provided by (Responsible Party):
Yang Yu, 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.

Condition or disease Intervention/treatment Phase
Coronary Atherosclerotic Heart Disease Procedure: A method of operation: LIMA-GSV-SCVBG Procedure: BIMA-SCVBG Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Estimated Study Start Date : November 30, 2017
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: LIMA-GSV-SCVBG Group
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.
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 Group
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.
Procedure: 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.




Primary Outcome Measures :
  1. The patency rate of bridge vessels and selective coronary vein [ Time Frame: 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 :
  1. Main adverse cardiovascular and cerebrovascular events [ Time Frame: 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.

  2. Wound complications [ Time Frame: 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.



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Ages Eligible for Study:   up to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03334110


Locations
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China, Beijing
Beijing An Zhen Hospital , Capital Medical University Recruiting
Beijing, Beijing, China
Contact: yang yu, doctor    13911534101    15915901281629@163.com   
Sponsors and Collaborators
Beijing Anzhen Hospital
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Responsible Party: Yang Yu, Professor;Chief Physician;, Beijing Anzhen Hospital
ClinicalTrials.gov Identifier: NCT03334110    
Other Study ID Numbers: Z151100004015177
First Posted: November 7, 2017    Key Record Dates
Last Update Posted: November 7, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Diseases
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases