Fasciotomy and Predilation for Radial Artery Grafts in CABG
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRuijin Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Scheduled for coronary artery bypass grafting (CABG) and planned use of radial artery (RA) grafts
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Radial Artery Harvesting With Fasciotomy and Predilation
Procedure/SurgeryAfter 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
Procedure/SurgeryPedicled 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.
Treatment groups
314 Participants
are divided into 2 treatment groupsGroup A: Fasciotomy and Predilation ArmExperimental treatment 1 intervention
Group B: No Fasciotomy or Predilation ArmActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
1-Year Composite event rate of all-cause death, myocardial Infarction, RA graft related revascularization, or RA graft failure
Time frame
At 1 year post-surgerySecondary outcomes
1
1-year incidence of 4 point Major Adverse Cardiovascular Events (4P-MACE)
4P-MACE was defined as a composite of all-cause death, myocardial infarction (MI), stroke, or any repeat revascularization (PCI or CABG).
Time frame
1 year post-surgery2
1-year incidence of 3 point-MACE
3P-MACE was defined as a composite of cardiovascular death, myocardial infarction, or stroke
Time frame
1 year post-CABG3
1-year incidence of all-cause death
Time frame
1 year post-CABG4
1-year incidence of cardiovascular death
Cardiovascular death includes death due to acute myocardial infarction, sudden cardiac death, heart failure, stroke, cardiovascular procedure, cardiovascular hemorrhage, or other cardiovascular causes, as adjudicated per ARC-2 definitions.
Time frame
1-year post-CABGOther outcomes
1
Median intraoperative RA graft blood flow
RA graft flow will be measured by transit-time flow measurement (TTFM) after completion of the RA graft anastomosis, reported in mL/min.
Time frame
Intraoperative2
Median intraoperative RA graft pulsatility index
Pulsatility index (PI) of the RA graft measured by TTFM after completion of the RA graft anastomosis.
Time frame
Intraoperative3
Incidence of intraoperative RA graft reverse flow
Proportion of participants with any reverse flow in the RA graft detected by TTFM after completion of the RA graft anastomosis.
Time frame
Intraoperative4
7-day incidence of patient-level RA graft failure (and its components)
RA graft failure is defined as modified FitzGibbon grade B, S, or O on CCTA, assessed by the independent Imaging Core Laboratory. Components include: Grade B: maximum diameter stenosis \>50% but not occluded; Grade S: "string sign" (patent but diffusely narrowed, visual diameter \<1 mm); Grade O: occlusion. A patient is considered to have a patient-level event if any RA graft is graded B, S, or O.
Time frame
7 days post-CABGSponsors and contacts
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Source ClinicalTrials.gov
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