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Status unknownNCT03334110Updated Nov 7, 2017

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

An interventional study of A method of operation: LIMA-GSV-SCVBG and BIMA-SCVBG in Coronary Atherosclerotic Heart Disease, sponsored by Beijing Anzhen Hospital. Status unknown at 1 site in China. Open to participants aged Up to 70 Years. Per ClinicalTrials.gov, last updated 2017-11-07.

Sponsored by Beijing Anzhen Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
320
Allocation
Randomized
Ages
Up to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Coronary Atherosclerotic Heart Disease
03

Who can participate

Ages eligible
Up to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
320 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • ProcedureA 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

  • ProcedureBIMA-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.

05

What researchers measure

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

    Time frame: 1-3 years

Secondary outcomes

  1. 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.

    Time frame: 1-3 years

  2. 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.

    Time frame: 1-3 years

06

Study locations

1 of 1 sites recruiting
  • Beijing An Zhen Hospital , Capital Medical University
    Beijing, Beijing, China
    Recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03334110
Lead sponsor
Beijing Anzhen Hospital
Responsible party
Yang Yu (Professor；Chief Physician；, Beijing Anzhen Hospital) — Principal investigator
First posted
Nov 7, 2017
Start date
Nov 30, 2017 (estimated)
Primary completion
Dec 2017 (estimated)
Completion
Sep 2018 (estimated)
Last update
Nov 7, 2017

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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