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NCT Number: NCT06014047

Radial Artery Versus No-touch Saphenous Vein

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fuwai Hospital Chinese Academay of Medical Science and National Center for Cardiovascular Diseases

Beijing, Beijing Municipality, 100037, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No-touch vein graft

Procedure

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.

radial artery graft

Procedure

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.

Primary outcomes

  1. Prevalence of graft patency

    Time frame: 12 months after procedure

    All 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 outcomes

  1. Prevalence of graft patency

    Time frame: 3 months, 3 years and 5 years after procedure

    All 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.

  2. Overall major adverse cardiac or cerebrovascular events (MACCE) rate

    Time frame: 3 months, 12 months, 3 years and 5 years after procedure

    MACCE includes death, myocardial infarction, stroke and/or repeat revascularization

  3. Cardiac death

    Time frame: 3 months, 12 months, 3 years and 5 years after procedure

    Death from any heart disease

  4. Documented non-lethal myocardial infarction

    Time frame: 3 months, 12 months, 3 years and 5 years after procedure

    Myocardial infarction is defined according to the most recent guideline

  5. Stroke

    Time frame: 3 months, 12 months, 3 years and 5 years after procedure

    An acute symptomatic episode of focal or global neurological dysfunction caused by brain, spinal, or retinal vascular injury as a result of hemorrhage or infarction

  6. Target lesion revascularization

    Time frame: 3 months, 12 months, 3 years and 5 years after procedure

    CABG or percutaneous coronary intervention

  7. Recurrence of Angina

    Time frame: 3 months, 12 months, 3 years and 5 years after procedure

    Recurrence of Angina

Study contacts

Contact information is provided by the study sponsor or research team.

Meice Tian, M.D.

CONTACT

[email protected]

+8613718863077

Shengshou Hu, M.D.

CONTACT

[email protected]

+86-10-88398359

Sponsors and collaborators

Lead sponsor

China National Center for Cardiovascular Diseases

Other Gov

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2030
First posted
Aug 28, 2023
Registry last updated
Oct 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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