NCT07057713

Brief Summary

This is a prospective, randomized, double-blind controlled trial comparing the clinical efficacy of total arterial grafting (internal thoracic artery and radial artery) versus conventional mixed grafting (internal thoracic artery and great saphenous vein) in the left coronary artery system during coronary artery bypass grafting (CABG). A total of 400 patients undergoing elective CABG at the Second Hospital of Jilin University will be enrolled and randomized into two groups. The primary endpoint is graft patency at 12 months postoperatively, evaluated by coronary angiography or CT angiography. Secondary outcomes include perioperative complications, major adverse cardiovascular events (MACE), and long-term clinical prognosis. The study aims to provide evidence-based guidance on optimal graft selection in CABG.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P50-P75 for not_applicable coronary-artery-disease

Timeline
17mo left

Started Aug 2026

Shorter than P25 for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 29, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 10, 2025

Completed
1.1 years until next milestone

Study Start

First participant enrolled

August 1, 2026

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2027

Last Updated

April 23, 2026

Status Verified

April 1, 2026

Enrollment Period

1 year

First QC Date

June 29, 2025

Last Update Submit

April 21, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Graft Patency Rate

    Graft patency will be assessed at 12 months after surgery by coronary angiography or coronary CT angiography. A patent graft is defined as one with \<50% stenosis and continuous flow. The proportion of patients with all coronary artery grafts remaining patent will be calculated and compared between groups.

    12 months after surgery

Secondary Outcomes (2)

  • Incidence of Major Adverse Cardiovascular Events

    Within 12 months after surgery

  • Incidence of Perioperative Complications

    Within 30 days after surgery

Study Arms (2)

Total Arterial Grafting Group

EXPERIMENTAL

Patients in this group will undergo coronary artery bypass grafting (CABG) with total arterial grafts to the left coronary artery system. The left internal thoracic artery (LITA) will be grafted to the left anterior descending artery (LAD), and the radial artery will be anastomosed to the obtuse marginal or diagonal branches of the circumflex artery. The right coronary artery, if revascularized, will receive a conventional vein graft.

Procedure: Total Arterial Grafting

Conventional Mixed Grafting Group

ACTIVE COMPARATOR

Patients in this group will receive conventional mixed grafting during CABG. The left internal thoracic artery (LITA) will be used for the LAD, while the great saphenous vein will be grafted to other branches of the left coronary artery system, such as the obtuse marginal or diagonal branches. The right coronary artery, if revascularized, will also be grafted using a vein.

Procedure: Conventional Mixed Grafting

Interventions

Coronary artery bypass grafting using only arterial conduits in the left coronary artery system. The left internal thoracic artery (LITA) is grafted to the LAD, and the radial artery is anastomosed to the obtuse marginal or diagonal branches. This approach avoids the use of saphenous vein grafts for the left coronary system.

Also known as: LITA + Radial Artery Grafting
Total Arterial Grafting Group

A standard coronary artery bypass grafting (CABG) procedure where the left internal thoracic artery (LITA) is grafted to the LAD, and saphenous vein grafts are used for the obtuse marginal or diagonal branches of the left coronary system. This approach represents the conventional mixed arterial-venous strategy.

Also known as: Mixed Arterial-Venous Grafting
Conventional Mixed Grafting Group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years
  • Diagnosed with multivessel coronary artery disease
  • Indicated for elective coronary artery bypass grafting (CABG) involving ≥3 coronary vessels
  • Right coronary artery stenosis \>75%
  • Able and willing to provide written informed consent

You may not qualify if:

  • Scheduled for concurrent cardiac procedures (e.g., valve surgery, congenital heart disease repair, aortic dissection surgery, atrial fibrillation ablation)
  • Severe stenosis of left or right subclavian artery
  • Unsuitable saphenous veins (e.g., bilateral varicosities)
  • Unsuitable radial artery as assessed preoperatively
  • History of intracranial hemorrhage or ischemic stroke within the past 14 days
  • Severe hepatic or renal insufficiency
  • Acute myocardial infarction within 72 hours prior to surgery
  • History of prior CABG or other cardiac surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Hospital of Jilin University

Changchun, Jilin, 130000, China

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Kexiang Liu

    Department of Cardiovascular Surgery, The Second Hospital of Jilin University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participants and outcome assessors will be blinded to the grafting strategy. The surgical team will not be blinded due to the nature of the intervention, but outcome evaluation will be conducted by independent, blinded assessors.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Patients undergoing elective CABG will be randomized 1:1 to receive either total arterial grafting or conventional mixed grafting in the left coronary system.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 29, 2025

First Posted

July 10, 2025

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

December 30, 2027

Last Updated

April 23, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations