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Fasciotomy and Predilation for Radial Artery Grafts in CABG
Sponsor: Ruijin Hospital
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.
Official title: Effect of Pedicled Harvesting With FascIotomy and PreDilation on Radial Artery Graft Outcomes After Coronary Artery Bypass Grafting: A Multicenter, Randomized, Participant and Assessor Blinded, Parallel- Controlled, Superiority Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
314
Start Date
2026-10
Completion Date
2029-06
Last Updated
2026-10-09
Healthy Volunteers
No
Interventions
Radial Artery Harvesting With Fasciotomy and Predilation
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.
Radial Artery Harvesting Without Fasciotomy or Predilation
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.
Locations (1)
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China