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

NCT03334110 | Unknown DMC

• 1 other identifier: Z151100004015177
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Atherosclerotic Heart Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Main adverse cardiovascular and cerebrovascular events

  1-3 years

• Wound complications

  1-3 years

Study Arms (2)

LIMA-GSV-SCVBG Group

EXPERIMENTAL

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

BIMA-SCVBG Group

OTHER

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

Interventions

A method of operation: LIMA-GSV-SCVBG PROCEDURE

On the experimental group,We treat patients with the operation of LIMA-GSV composited Y graft and anastomose the GSV with selective coronary vein

LIMA-GSV-SCVBG Group

BIMA-SCVBG PROCEDURE

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.

BIMA-SCVBG Group

Eligibility Criteria

• Age: Up to 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead

Study Sites (1)

Beijing An Zhen Hospital , Capital Medical University

Beijing, Beijing Municipality, China

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor；Chief Physician；

Study Record Dates

• First Submitted: September 17, 2017
• First Posted: November 7, 2017
• Study Start: November 30, 2017
• Primary Completion: December 1, 2017
• Study Completion: September 1, 2018
• Last Updated: November 7, 2017

Record last verified: 2017-11

Locations

CN (1)