Fasciotomy and Predilation for Radial Artery Grafts in CABG

NCT07868692 | Not Yet Recruiting DMC

• 1 other identifier: KY-2026-672
• Study Type: interventional
• Target: 314
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if a new way to prepare a radial artery graft during coronary artery bypass grafting (CABG) can improve outcomes for adults having this surgery. CABG is a heart surgery that uses a blood vessel to bypass blocked arteries in the heart. The radial artery is a blood vessel taken from the arm and used as a graft. The new way combines two steps: Fasciotomy: a small cut in the tissue around the graft to release pressure. Predilation: gently filling the graft with a medicine solution to widen it and check for damage. Researchers will compare this new way with the standard way of harvesting the radial artery. The main questions it aims to answer are: Does the new way lower the chance of death, heart attack, another procedure to restore blood flow through the graft, or graft failure within 1 year after surgery? Does it improve blood flow and keep the radial artery graft open? Is it safe? Participants will: Be adults scheduled to have CABG using a radial artery graft. Be assigned by chance to one of two groups: the new way or the standard way. Have CABG surgery. Visit the clinic at 7 days, 30 days, 6 months, and 12 months after surgery. Have a special heart scan (coronary computed tomography angiography, CCTA) at 7 days and 12 months to check the graft. Allow researchers to collect medical information and record any health problems. Researchers will compare the two groups to see if the new way works better than the standard way.

Conditions

Coronary Artery Bypass; Radial Artery Grafts

Keywords

CABG; Radial artery grafts

Outcome Measures

Primary Outcomes (1)

• 1-Year Composite event rate of all-cause death, myocardial Infarction, RA graft related revascularization, or RA graft failure

  At 1 year post-surgery

Secondary Outcomes (11)

• 1-year incidence of 4 point Major Adverse Cardiovascular Events (4P-MACE)

  1 year post-surgery

• 1-year incidence of 3 point-MACE

  1 year post-CABG

• 1-year incidence of all-cause death

  1 year post-CABG

• 1-year incidence of cardiovascular death

  1-year post-CABG

• 1-year incidence of myocardial infarction

  1-year post-CABG

Other Outcomes (5)

• Median intraoperative RA graft blood flow

  Intraoperative

• Median intraoperative RA graft pulsatility index

  Intraoperative

• Incidence of intraoperative RA graft reverse flow

  Intraoperative

Study Arms (2)

Fasciotomy and Predilation Arm

EXPERIMENTAL

Procedure: Radial Artery Harvesting With Fasciotomy and Predilation

No Fasciotomy or Predilation Arm

ACTIVE COMPARATOR

Procedure: Radial Artery Harvesting Without Fasciotomy or Predilation

Interventions

Radial Artery Harvesting With Fasciotomy and Predilation PROCEDURE

After pedicled radial artery (RA) harvesting, a single-aspect fasciotomy of the graft pedicle is performed to release the fascial sheath along the harvested RA graft, with care taken to avoid injury to the RA and surrounding structures. The harvested RA graft is then predilated with a verapamil plus nitroglycerin (VG) solution (verapamil 5 mg, nitroglycerin 2.5 mg, heparin 500 U, 8.4% NaHCO₃ 0.2 mL, and Ringer's lactate solution 300 mL) to relieve vasospasm, restore luminal caliber, and assess graft integrity and the adequacy of branch ligation. The procedure is performed in accordance with a standardized surgical protocol. Any deviations deemed clinically necessary are documented.

Fasciotomy and Predilation Arm

Radial Artery Harvesting Without Fasciotomy or Predilation PROCEDURE

Pedicled radial artery (RA) harvesting is performed through a forearm incision along the RA course, preserving the surrounding fascia and adipose tissue. The RA is dissected bluntly under direct visualization or with permitted assistance, avoiding direct clamping of the vessel. Following harvesting, the RA graft is prepared without fasciotomy or VG solution predilation.

No Fasciotomy or Predilation Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Scheduled for coronary artery bypass grafting (CABG) and planned use of radial artery (RA) grafts

You may not qualify if:

• Emergency CABG or redo CABG
• Planned concomitant cardiac or non-cardiac surgery
• Contraindications to coronary computed tomography angiography (CCTA), including pregnancy, uncontrolled severe iodine contrast allergy, or severe renal insufficiency (eGFR \< 30 mL/min/1.73 m²)
• Any condition that, in the investigator's judgment, would preclude safe participation, completion of informed consent, or follow-up
• Inability to provide written informed consent

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location

MeSH Terms

Interventions

Fasciotomy

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Yunpeng Zhu

  Ruijin Hospital Shanghai Jiao Tong University School of Medicine, Shanghai, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yunpeng Zhu

CONTACT

+86 02164370045; zyp12220@rjh.com.cn

Haonan Huang

CONTACT

hhn3141547334@sjtu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: In addition to participants and outcomes assessors, the following parties are masked to treatment allocation: CCTA image readers at the independent imaging core laboratory, members of the independent endpoint adjudication committee, and statisticians performing analyses before unblinding. The operating surgeon and site staff involved in the surgical procedure are not masked because of the nature of the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of clinical research, Department of Cardiovascular Surgery

Study Record Dates

• First Submitted: October 4, 2026
• First Posted: October 9, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): June 1, 2029
• Last Updated: October 9, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

CN (1)