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

NCT ID: NCT03334110

Last Updated: 2017-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-30

Study Completion Date

2018-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Coronary Atherosclerotic Heart Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

A method of operation: LIMA-GSV-SCVBG

Intervention Type 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

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.

Group Type OTHER

BIMA-SCVBG

Intervention Type 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.

Interventions

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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

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Anzhen Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yang Yu

Professor；Chief Physician；

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Beijing An Zhen Hospital , Capital Medical University

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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yang yu, doctor

Role: primary

Other Identifiers

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Z151100004015177

Identifier Type: -

Identifier Source: org_study_id