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Radial Artery Versus No-touch Saphenous Vein

Graft Patency Between the Radial Artery and the No-touch Saphenous Vein in Coronary Artery Bypass Grafting Study (GRAFT-CAB Study)

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06014047
Enrollment
774
Registered
2023-08-28
Start date
2023-11-01
Completion date
2030-10-30
Last updated
2023-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

coronary artery disease, coronary artery bypass grafting

Brief summary

This study evaluates the short-term and long-term patency of the radial artery and the No-touch vein in patients undergoing isolated on-pump/off-pump coronary artery bypass graft (CABG) surgery. A total of at least 774 patients undergoing isolated on-pump/off-pump CABG will be consecutively recruited from Fuwai Hospital and randomly assigned to receive radial artery or No-touch saphenous vein as their second graft. All participants will be invited for clinical follow-up and 64-slice multislice computed tomography angiography (MSCTA) analysis at 3 months and 12 months post-operatively.

Detailed description

CABG is still the treatment of choice for ischemic heart disease. However, restenosis or occlusion may occur to graft vessels, leading to postoperative myocardial ischemia and subsequent clinical events. Long-term angiographic follow-up demonstrated that vein graft restenosis and occlusion are common among those receiving CABG, with a vein graft patency of less than 50% at 15 years postoperatively. A novel approach to harvesting the vein is called No-touch technique (NT), which can avoid mechanical damage to the vein wall. Previous studies showed that No-touch saphenous vein grafts (NT-SVG) has a 96.3% postoperative graft patency rate at 12 months, compared to 93.5% of conventional saphenous vein grafts (con-SVGs). Thus, the No-touch technique can significantly reduce postoperative graft occlusion. Radial artery(RA) as an arterial material for CABG surgery has a better long-term patency than con-SVG, up to 83% at 10 years. Using radial artery as the second graft for CABG may provide additional clinical benefit. However, the risk of perioperative vasospasm and graft occlusion due to competitive blood flow limit the using of radial artery. Therefore, only the No-touch vein and the radial artery can improve the graft patency. Only one randomized clinical trial(RCT) compared the RA and NT-vein, and this study is limited by irregular post-operative management and small sample size from single center. This prospective single-center study aims to compare the short-term and long-term graft patency between the No-touch vein and the radial artery. This study will consecutively enroll at least 774 patients undergoing isolated on-pump/off-pump CABG. After obtaining informed written consent, participants will be randomly allocated to either the No-touch or the radial artery group. At baseline, participants will be interviewed to collect detailed information about on demographics, socioeconomic status, cardiovascular risk factors, clinical characteristics, treatments, in-hospital outcomes, general and disease-specific quality of life, function and mental status. During the follow-ups, the investigators will collect information about clinical outcomes events, long-term treatments, function, quality of life, symptoms, and medical care during the recovery period. All participants will be invited for 64-slice multi-slice computed tomography angiography (MSCTA) analysis at 3 months and 12 months post-operatively for graft patency evaluation. The data adjudicators and computed tomography(CT) reviewers will be blinded to the study. Due to the nature of this study, the operating surgeons, anesthetists and other operative room staff will not be blind in this study. Owing to the use of radial artery need approved by the participant, so participants will also not be blind in this study, By comparing the short-term and long-term graft patency between the No-touch vein and radial artery groups, this study will contribute major evidence of the possible superiority between two different grafts, so as to improve patient outcomes after CABG surgery.

Interventions

Two No-touch saphenous vein grafts anastomose to the right coronary and left coronary system. All participants also acquired Left intrathoracic artery(LITA)-left anterior decending artery(LAD) anastomosis to complete the revascularization.

One radial artery graft and one conventional saphenous vein graft anastomose to the right coronary or left coronary system basing on surgeons' decision. All participants also acquired Left intrathoracic artery(LITA)-left anterior decending artery(LAD) anastomosis to complete the revascularization.

Sponsors

China National Center for Cardiovascular Diseases
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age more than 18 years old * First time undergo isolated CABG surgery * Severe three-vessel disease (Left anterior decending artery, Left circumflex artery, Right coronoary artery lesion with more than 75% stenosis)

Exclusion criteria

* Urgent or Redo CABG surgery * Concomitant cardiac or vascular procedures (i.e. valve repair or replacement, Morrow procedure) * A positive Allen test, radial artery plaque on ultrasound or a history of vasculitis or Raynaud's syndrome * Varicose great saphenous vein or venous tortuosity and judged as can not be used in operation by surgeons * Known allergy to radiographic contrast media * Planed endarterectomy of coronary artery before surgery * Malignant tumor or other severe systemic diseases * Combined with other irreversible organ failures * Contraindications for dual antiplatelet therapy, such as active gastroduodenal ulcer * Participant of other ongoing clinical trials in 30 days.

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of graft patency12 months after procedureAll participants will be invited to return to their operating hospitals for 64-slice multi-slice computed tomography angiography to determine patencies of the graft vessels.

Secondary

MeasureTime frameDescription
Prevalence of graft patency3 months, 3 years and 5 years after procedureAll participants will be invited to return to their operating hospitals for 64-slice multi-slice computed tomography angiography to determine patencies of the graft vessels.
Overall major adverse cardiac or cerebrovascular events (MACCE) rate3 months, 12 months, 3 years and 5 years after procedureMACCE includes death, myocardial infarction, stroke and/or repeat revascularization
Cardiac death3 months, 12 months, 3 years and 5 years after procedureDeath from any heart disease
Documented non-lethal myocardial infarction3 months, 12 months, 3 years and 5 years after procedureMyocardial infarction is defined according to the most recent guideline
Stroke3 months, 12 months, 3 years and 5 years after procedureAn acute symptomatic episode of focal or global neurological dysfunction caused by brain, spinal, or retinal vascular injury as a result of hemorrhage or infarction
Target lesion revascularization3 months, 12 months, 3 years and 5 years after procedureCABG or percutaneous coronary intervention
Recurrence of Angina3 months, 12 months, 3 years and 5 years after procedureRecurrence of Angina

Countries

China

Contacts

Primary ContactShengshou Hu, M.D.
shengshouhu@yahoo.com+86-10-88398359
Backup ContactMeice Tian, M.D.
tianmeice@fuwaihospital.org+8613718863077

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026