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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03334110
Enrollment
320
Registered
2017-11-07
Start date
2017-11-30
Completion date
2018-09-30
Last updated
2017-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Atherosclerotic Heart Disease

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.

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.

Sponsors

Beijing Anzhen Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
No minimum to 70 Years
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

* 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.

Design outcomes

Primary

MeasureTime frameDescription
The patency rate of bridge vessels and selective coronary vein1-3 yearsWe 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

MeasureTime frameDescription
Main adverse cardiovascular and cerebrovascular events1-3 yearsWe 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.
Wound complications1-3 yearsWe 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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026