Coronary Artery DiseaseNCT06014047
Radial Artery Versus No-touch Saphenous Vein
A study testing No-touch vein graft and Radial artery graft in people with Coronary Artery Disease, run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- No-touch vein graft and Radial artery graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 774 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2023to 30 Oct 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 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)
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Fuwai Hospital Chinese Academay of Medical Science and National Center for Cardiovascular Diseases
Beijing, Beijing Municipality, 100037
About this study
Official title: Graft Patency Between the Radial Artery and the No-touch Saphenous Vein in Coronary Artery Bypass Grafting Study (GRAFT-CAB Study)
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.
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- No-touch vein graft, Radial artery graft
- Keywords
- coronary artery disease, coronary artery bypass grafting
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No-touch vein graftProcedure or surgery
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 graftProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| No-Touch vein | Experimental | No-touch vein group has two No-touch saphenous vein grafts, anastomose to the right coronary or left coronary system. All patients also acquired LITA-LAD anastomosis to complete the revascularization. Receives: Procedure: No-touch vein graft |
| Radial artery | Active comparator | Radial artery group has one radial artery graft and one conventional saphenous vein graft, anastomose to the right coronary or left coronary system basing on surgeons' decision. All patients also acquired LITA-LAD anastomosis to complete the revascularization. Receives: Procedure: Radial artery graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of graft patency
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.
Measured: 12 months after procedure
Secondary outcomes (7)
Prevalence of graft patency
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.
Measured: 3 months, 3 years and 5 years after procedure
Overall major adverse cardiac or cerebrovascular events (MACCE) rate
MACCE includes death, myocardial infarction, stroke and/or repeat revascularization
Measured: 3 months, 12 months, 3 years and 5 years after procedure
Cardiac death
Death from any heart disease
Measured: 3 months, 12 months, 3 years and 5 years after procedure
Documented non-lethal myocardial infarction
Myocardial infarction is defined according to the most recent guideline
Measured: 3 months, 12 months, 3 years and 5 years after procedure
Stroke
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
Measured: 3 months, 12 months, 3 years and 5 years after procedure
Target lesion revascularization
CABG or percutaneous coronary intervention
Measured: 3 months, 12 months, 3 years and 5 years after procedure
Recurrence of Angina
Recurrence of Angina
Measured: 3 months, 12 months, 3 years and 5 years after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2023
- Study start1 Nov 2023 (estimated)
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by China National Center for Cardiovascular DiseasesThe 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
- None (open label)
- Enrolment
- 774 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06014047
- Sponsor's protocol ID
- 2023-2109
- Status last verified
- Aug 2023
- First submitted
- 23 Aug 2023
- Last updated
- 17 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tian M, Wang X, Sun H, Feng W, Song Y, Lu F, Wang L, Wang Y, Xu B, Wang H, Liu S, Liu Z, Chen Y, Miao Q, Su P, Yang Y, Guo S, Lu B, Sun Z, Liu K, Zhang C, Wu Y, Xu H, Zhao W, Han C, Zhou X, Wang E, Huo X, Hu S. No-Touch Versus Conventional Vein Harvesting Techniques at 12 Months After Coronary Artery Bypass Grafting Surgery: Multicenter Randomized, Controlled Trial. Circulation. 2021 Oct 5;144(14):1120-1129. doi: 10.1161/CIRCULATIONAHA.121.055525. Epub 2021 Sep 13.
PubMed 34510911Nappi F, Bellomo F, Nappi P, Chello C, Iervolino A, Chello M, Acar C. The Use of Radial Artery for CABG: An Update. Biomed Res Int. 2021 Apr 7;2021:5528006. doi: 10.1155/2021/5528006. eCollection 2021.
PubMed 33928147Zhang F, Tian M, Wang X, Zhang H, Zhou X, Liu R, Liu R, Jin Z, Zhang C, Wang X. Rationale and design of a single-center randomized trial to compare the graft patency between the radial artery and the no-touch saphenous vein in coronary artery bypass grafting surgery (GRAFT-CAB Study). Am Heart J. 2024 Aug;274:46-53. doi: 10.1016/j.ahj.2024.05.001. Epub 2024 May 6.
PubMed 38710379
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Graft Patency Between the Radial Artery and the No-touch Saphenous Vein in Coronary Artery Bypass Grafting Study (GRAFT-CAB Study)
- ClinicalTrials.gov ID
- NCT06014047
- Acronym / sponsor ID
- 2023-2109
- Conditions
- Coronary Artery Disease
- Keywords
- coronary artery disease, coronary artery bypass grafting
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 774 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Oct 2030 (estimated)
- First posted
- 28 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No-Touch vein | Experimental | Procedure: No-touch vein graftNo-touch vein group has two No-touch saphenous vein grafts, anastomose to the right coronary or left coronary system. All patients also acquired LITA-LAD anastomosis to complete the revascularization. |
| Radial artery | Active comparator | Procedure: Radial artery graftRadial artery group has one radial artery graft and one conventional saphenous vein graft, anastomose to the right coronary or left coronary system basing on surgeons' decision. All patients also acquired LITA-LAD anastomosis to complete the revascularization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No-touch vein graftTwo 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. | Procedure or surgery | No-Touch vein |
| Radial artery graftOne 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. | Procedure or surgery | Radial artery |
Primary outcome
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.
7 secondary outcomes
Prevalence of graft patency
Time frame: 3 months, 3 years and 5 years after procedure
Overall major adverse cardiac or cerebrovascular events (MACCE) rate
Time frame: 3 months, 12 months, 3 years and 5 years after procedure
Cardiac death
Time frame: 3 months, 12 months, 3 years and 5 years after procedure
Documented non-lethal myocardial infarction
Time frame: 3 months, 12 months, 3 years and 5 years after procedure
Stroke
Time frame: 3 months, 12 months, 3 years and 5 years after procedure
Target lesion revascularization
Time frame: 3 months, 12 months, 3 years and 5 years after procedure
Recurrence of Angina
Time frame: 3 months, 12 months, 3 years and 5 years after procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2023.
- Results publication: PubMed 34510911Tian M, Wang X, Sun H, Feng W, Song Y, Lu F, Wang L, Wang Y, Xu B, Wang H, Liu S, Liu Z, Chen Y, Miao Q, Su P, Yang Y, Guo S, Lu B, Sun Z, Liu K, Zhang C, Wu Y, Xu H, Zhao W, Han C, Zhou X, Wang E, Huo X, Hu S. No-Touch Versus Conventional Vein Harvesting Techniques at 12 Months After Coronary Artery Bypass Grafting Surgery: Multicenter Randomized, Controlled Trial. Circulation. 2021 Oct 5;144(14):1120-1129. doi: 10.1161/CIRCULATIONAHA.121.055525. Epub 2021 Sep 13.
- Results publication: PubMed 33928147Nappi F, Bellomo F, Nappi P, Chello C, Iervolino A, Chello M, Acar C. The Use of Radial Artery for CABG: An Update. Biomed Res Int. 2021 Apr 7;2021:5528006. doi: 10.1155/2021/5528006. eCollection 2021.
- Derived from this study: PubMed 38710379Zhang F, Tian M, Wang X, Zhang H, Zhou X, Liu R, Liu R, Jin Z, Zhang C, Wang X. Rationale and design of a single-center randomized trial to compare the graft patency between the radial artery and the no-touch saphenous vein in coronary artery bypass grafting surgery (GRAFT-CAB Study). Am Heart J. 2024 Aug;274:46-53. doi: 10.1016/j.ahj.2024.05.001. Epub 2024 May 6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No-touch vein graft and Radial artery graft in people with Coronary Artery Disease, run by China National Center for Cardiovascular Diseases at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shengshou Hu, M.D. (+86-10-88398359, shengshouhu@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of graft patency (time frame: 12 months after procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06014047, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2023.