Coronary Artery BypassRAPID-CABGNCT07868692
Fasciotomy and Predilation for Radial Artery Grafts in CABG
A study testing Radial Artery Harvesting With Fasciotomy and Predilation and Radial Artery Harvesting Without Fasciotomy or Predilation in people with Coronary Artery Bypass and Radial Artery Grafts, run by Ruijin Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Bypass, Radial Artery Grafts
- What is being tested?
- Radial Artery Harvesting With Fasciotomy and Predilation and Radial Artery Harvesting Without Fasciotomy or Predilation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 314 participants
- Where
- 1 siteChina
- Study dates
- Oct 2026to Jun 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled for coronary artery bypass grafting (CABG) and planned use of radial artery (RA) grafts
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Haonan Huang contact
China1 site
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Yunpeng Zhu, +86 02164370045, zyp12220@rjh.com.cn
Yunepng Zhu
About this study
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
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:
Read more
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
- Being tested
- Radial Artery Harvesting With Fasciotomy and Predilation, Radial Artery Harvesting Without Fasciotomy or Predilation
- Keywords
- CABG, Radial artery grafts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radial Artery Harvesting With Fasciotomy and PredilationProcedure or surgery
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 PredilationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Fasciotomy and Predilation Arm | Experimental | Not described Receives: Procedure: Radial Artery Harvesting With Fasciotomy and Predilation |
| No Fasciotomy or Predilation Arm | Active comparator | Not described Receives: Procedure: Radial Artery Harvesting Without Fasciotomy or Predilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-Year Composite event rate of all-cause death, myocardial Infarction, RA graft related revascularization, or RA graft failure
Measured: At 1 year post-surgery
Secondary outcomes (11)
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).
Measured: 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
Measured: 1 year post-CABG
1-year incidence of all-cause death
Measured: 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.
Measured: 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
Measured: 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.
Measured: 1-year post-CABG
1-year incidence of stroke
Measured: 1-year post-CABG
1-year incidence of any revascularization
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 year post-CABG
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery BypassStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 314 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhu yunpeng, Ruijin Hospital
- Investigators
- Yunpeng Zhu, Principal investigator, Ruijin Hospital Shanghai Jiao Tong University School of Medicine, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07868692
- Sponsor's protocol ID
- KY-2026-672
- Acronym
- RAPID-CABG
- Status last verified
- Oct 2026
- First submitted
- 4 Oct 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes