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

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

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 Overview

• Status: Unknown
• Conditions: Coronary Atherosclerotic Heart Disease
• Intervention / Treatment: Procedure: A method of operation: LIMA-GSV-SCVBG; Procedure: BIMA-SCVBG

• Study Type: Interventional
• Enrollment (Anticipated): 320
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Recruiting
      • Beijing An Zhen Hospital , Capital Medical University
      • Contact: yang yu, doctor; Phone Number: 13911534101; Email: 15915901281629@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Beijing Anzhen Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): November 30, 2017
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): September 1, 2018

Study Registration Dates

• First Submitted: September 17, 2017
• First Submitted That Met QC Criteria: November 2, 2017
• First Posted (Actual): November 7, 2017

Study Record Updates

• Last Update Posted (Actual): November 7, 2017
• Last Update Submitted That Met QC Criteria: November 2, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia
• Other Study ID Numbers: Z151100004015177

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No