An interventional study of Radial Artery Harvesting With Fasciotomy and Predilation and Radial Artery Harvesting Without Fasciotomy or Predilation in Coronary Artery Bypass and Radial Artery Grafts, sponsored by Ruijin Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Ruijin Hospital · Not applicable, Interventional, and Treatment
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.
Ruijin Hospital is the lead sponsor of 667 studies on the registry; 376 are open to participants now.
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Exclusion Criteria:
Procedure: Radial Artery Harvesting With Fasciotomy and Predilation
Procedure: Radial Artery Harvesting Without Fasciotomy or 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.
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.
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-surgery
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-surgery
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-CABG
1-year incidence of all-cause death
Time frame: 1 year post-CABG
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-CABG
1-year incidence of myocardial infarction
Myocardial infarction was defined using the Fifth Universal Definition of Myocardial Infarction, including acute myocardial injury with a dynamic rise and/or fall in cardiac troponin, with at least one value above the sex-specific 99th percentile upper reference limit, together with clinical evidence of acute myocardial ischemia
Time frame: 1-year post-CABG
1-year incidence of RA graft-related myocardial infarction
RA graft-related myocardial infarction is defined as myocardial infarction occurring after CABG during follow-up, characterized by new or presumed new regional wall motion abnormality or loss of viable myocardium in the myocardial territory subtended by the RA graft, after exclusion of other graft-related or non-graft causes. Angiographic or CCTA evidence of new RA graft failure is supportive but not required.
Time frame: 1-year post-CABG
1-year incidence of stroke
Time frame: 1-year post-CABG
1-year incidence of any revascularization
Time frame: 1 year post-CABG
1-year incidence of RA graft-related revascularization
RA graft-related revascularization is defined as any PCI or CABG involving the RA graft or its target vessel.
Time frame: 1 year post-CABG
1-year 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: 1 year post-CABG
1-year Median RA graft Diameter
Diameter of the RA graft is measured on postoperative CCTA. The minimum diameter along the RA graft is used; grade S grafts are assigned a diameter of 1 mm, and grade O grafts are assigned a diameter of 0 mm.
Time frame: 1 year post-CABG
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: Intraoperative
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: Intraoperative
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: Intraoperative
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-CABG
7-day Median RA graft diameter
Diameter of the RA graft is measured on postoperative CCTA. The minimum diameter along the RA graft is used; grade S grafts are assigned a diameter of 1 mm, and grade O grafts are assigned a diameter of 0 mm.
Time frame: 7 day post-CABG
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Dec 2028, 26 months later.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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