Coronary Artery DiseaseNCT03126409
No-Touch Versus Conventional Saphenous Vein Harvesting Technique
A study testing No-Touch vein harvesting technique and Conventional vein harvesting 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 patency of vein graft harvested by the No-Touch technique compared to that by the conventional approach 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 harvesting technique and Conventional vein harvesting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,655 participants
- Where
- 1 siteChina
- Study dates
- 14 May 2017to 30 Dec 2029
- 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
- Patients receiving first time isolated on-pump/off-pump CABG
- Patients with at least one available saphenous vein graft
Who cannot join
- Need for a concomitant cardiac or vascular surgeries (i.e. valve repair or replacement, Maze surgery)
- Redo-CABG
- Emergent CABG
- Using vascular stapler for anastomosis
- Endarterectomy of coronary artery during surgery
- Left ventricular repair due to ventricular aneurysm
Show all 10Show fewer
- Combined with malignant tumor or other severe systemic conditions
- Severe renal insufficiency (i.e. creatinine >200 μmol/L)
- Contraindications for dual antiplatelet therapy, such as active gastroduodenal ulcer
- Participants of another ongoing clinical trials
Trial locations and contacts
1 site in 1 country.
China1 site
Fuwai Hospital Chinese Academay of Medical Science and National Center for Cardiovascular Diseases
Beijing, Beijing Municipality, 100037
About this study
Official title: A Multicenter Randomized Trial to Compare the Graft Patency Between No-Touch Vein Harvesting Technique and Conventional Approach in Coronary Artery Bypass Graft Surgery: the PATENCY Study
This study evaluates the short-term patency of vein graft harvested by the No-Touch technique compared to that by the conventional approach in patients undergoing isolated on-pump/off-pump coronary artery bypass graft (CABG) surgery. a total of at least 2000 patients undergoing isolated on-pump/off-pump CABG will be consecutively recruited from 7 hospitals across China and randomly assigned to receive No-Touch saphenous vein harvesting or conventional approach. All participants will be invited for clinical follow-up and 64-slice multislice computed tomography angiography (MSCTA) analysis at 3 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. Besides, it is found that graft occlusion may occur as early as 3 months after the surgery. It is, therefore, a major priority to improve the short-term postoperative vein graft patency so as to achieve better prognosis for patients.
Saphenous vein, the currently most frequently used graft material, occupies over 70% of all graft vessels.
Multiple factors may contribute to the early restenosis or occlusion of the vein grafts, including anastomosis technique, graft vessel quality, target lesion site and degree of stenosis, perioperative coagulating function, etc. The No-Touch technique focuses on saphenous vein graft harvesting, featured by preserving the surrounding tissue of the vein while at the same time avoiding manual distension. This technique has been reported associated with better short and long-term vein graft patency. However, these results mostly came from small-scale, single-center studies, therefore could hardly be recognized as high-level evidence for generalization of the technique.
This prospective multi-center study aims to compare the short-term saphenous vein graft patency harvested by the No-Touch technique and the conventional approach. This study will consecutively enroll 2000 patients undergoing isolated on-pump/off-pump CABG in 7 hospitals of China. After obtaining informed written consent, participants will be randomly allocated to either the No-Touch harvesting or conventional approach 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 post-operatively for graft patency evaluation.
The patients, data adjudicators and 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.
By comparing the short-term graft patency between the No-Touch and conventional vein harvesting groups, this study will contribute major evidence of the possible superiority of this technique, so as to improve patient outcomes after CABG surgery.
- Conditions
- Coronary Artery Disease
- Being tested
- No-Touch vein harvesting technique, Conventional vein harvesting
- Keywords
- coronary artery disease, coronary artery bypass graft
- 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 harvesting techniqueProcedure or surgery
The No-Touch technique focuses on saphenous vein graft harvesting, featured by preserving the surrounding tissue of the vein while at the same time avoiding manual distension.
Conventional vein harvestingProcedure or surgery
During saphenous vein harvesting, surrounding tissue of the vein is stripped off, and manual distension is routinely performed
| Study group | Role | What they receive |
|---|---|---|
| No-Touch vein harvesting technique | Experimental | During saphenous vein harvesting, surrounding tissue of the vein is preserved, and manual distension of the vein graft is avoided Receives: Procedure: No-Touch vein harvesting technique |
| Conventional vein harvesting | Active comparator | During saphenous vein harvesting, surrounding tissue of the vein is stripped off, and manual distension is routinely performed Receives: Procedure: Conventional vein harvesting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of graft occlusion
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 month after procedure
Secondary outcomes (8)
Prevalence of graft occlusion
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: 1, 3, 5, 7, and 10 years after procedure
Overall major adverse cardiac or cerebrovascular events (MACCE) rate
MACCE includes death, myocardial infarction, stroke and/or repeat revascularization
Measured: 3 month , 1, 3, 5, 7, and 10 years after procedure
Cardiac death
death from any heart disease
Measured: 3 month , 1, 3, 5, 7, and 10 years after procedure
Documented non-lethal myocardial infarction
Myocardial infarction is defined according to the most recent guideline
Measured: 3 month , 1, 3, 5, 7, and 10 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 month , 1, 3, 5, 7, and 10 years after procedure
Target lesion revascularization
CABG or percutaneous coronary intervention
Measured: 3 month , 1, 3, 5, 7, and 10 years after procedure
Recurrence of Angina
recurrence of unstable angina
Measured: 3 month, 1, 3, 5, 7, and 10 years after procedure
Rehospitalization due to cardiac reason
Rehospitalization due to cardiac reason
Measured: 3, 5, 7, and 10 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 posted24 Apr 2017
- Study start14 May 2017
- Primary completion30 Dec 2029 (estimated)
- Study completion30 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 2,655 participants (actual)
Sponsor and investigators
- Lead sponsor
- China National Center for Cardiovascular Diseases
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03126409
- Sponsor's protocol ID
- 20170414
- Status last verified
- Oct 2024
- First submitted
- 19 Apr 2017
- Last updated
- 4 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang X, Tian M, Zheng Z, Gao H, Wang Y, Wang L, Hu S. Rationale and design of a multicenter randomized trial to compare the graft patency between no-touch vein harvesting technique and conventional approach in coronary artery bypass graft surgery. Am Heart J. 2019 Apr;210:75-80. doi: 10.1016/j.ahj.2018.11.011. Epub 2018 Dec 6.
PubMed 30743210Tian M, Wang X, Feng W, Wang H, Liu S, Liu Z, Chen Y, Miao Q, Su P, Li X, Wang Y, Lu B, Chen K, Zhang C, Hu S. No-touch versus conventional vein in coronary artery bypass grafting: three year follow-up of multicentre randomised PATENCY trial. BMJ. 2025 Apr 30;389:e082883. doi: 10.1136/bmj-2024-082883.
PubMed 40306935Tian M, Xu B, Chen L, Wu F, Zhang R, Guan C, Xie L, Wang X, Hu S. Outcomes of quantitative flow ratio-based functional incomplete revascularization after coronary artery bypass grafting surgery. J Thorac Cardiovasc Surg. 2024 Aug;168(2):548-558.e13. doi: 10.1016/j.jtcvs.2023.03.032. Epub 2023 May 7.
PubMed 37160216Tian 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 34510911
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized Trial to Compare the Graft Patency Between No-Touch Vein Harvesting Technique and Conventional Approach in Coronary Artery Bypass Graft Surgery: the PATENCY Study
- ClinicalTrials.gov ID
- NCT03126409
- Acronym / sponsor ID
- 20170414
- Conditions
- Coronary Artery Disease
- Keywords
- coronary artery disease, coronary artery bypass graft
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,655 participants (actual)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 14 May 2017 (actual)
- Primary completion
- 30 Dec 2029 (estimated)
- Study completion
- 30 Dec 2029 (estimated)
- First posted
- 24 Apr 2017 (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 patency of vein graft harvested by the No-Touch technique compared to that by the conventional approach in patients undergoing isolated on-pump/off-pump coronary artery bypass graft (CABG) surgery. a total of at least 2000 patients undergoing isolated on-pump/off-pump CABG will be consecutively recruited from 7 hospitals across China and randomly assigned to receive No-Touch saphenous vein harvesting or conventional approach. All participants will be invited for clinical follow-up and 64-slice multislice computed tomography angiography (MSCTA) analysis at 3 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. Besides, it is found that graft occlusion may occur as early as 3 months after the surgery. It is, therefore, a major priority to improve the short-term postoperative vein graft patency so as to achieve better prognosis for patients.
Saphenous vein, the currently most frequently used graft material, occupies over 70% of all graft vessels.
Multiple factors may contribute to the early restenosis or occlusion of the vein grafts, including anastomosis technique, graft vessel quality, target lesion site and degree of stenosis, perioperative coagulating function, etc. The No-Touch technique focuses on saphenous vein graft harvesting, featured by preserving the surrounding tissue of the vein while at the same time avoiding manual distension. This technique has been reported associated with better short and long-term vein graft patency. However, these results mostly came from small-scale, single-center studies, therefore could hardly be recognized as high-level evidence for generalization of the technique.
This prospective multi-center study aims to compare the short-term saphenous vein graft patency harvested by the No-Touch technique and the conventional approach. This study will consecutively enroll 2000 patients undergoing isolated on-pump/off-pump CABG in 7 hospitals of China. After obtaining informed written consent, participants will be randomly allocated to either the No-Touch harvesting or conventional approach 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 post-operatively for graft patency evaluation.
The patients, data adjudicators and 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.
By comparing the short-term graft patency between the No-Touch and conventional vein harvesting groups, this study will contribute major evidence of the possible superiority of this technique, so as to improve patient outcomes after CABG surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No-Touch vein harvesting technique | Experimental | Procedure: No-Touch vein harvesting techniqueDuring saphenous vein harvesting, surrounding tissue of the vein is preserved, and manual distension of the vein graft is avoided |
| Conventional vein harvesting | Active comparator | Procedure: Conventional vein harvestingDuring saphenous vein harvesting, surrounding tissue of the vein is stripped off, and manual distension is routinely performed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients receiving first time isolated on-pump/off-pump CABG
- Patients with at least one available saphenous vein graft
Key exclusion criteria (10 listed)
- Need for a concomitant cardiac or vascular surgeries (i.e. valve repair or replacement, Maze surgery)
- Redo-CABG
- Emergent CABG
- Using vascular stapler for anastomosis
- Endarterectomy of coronary artery during surgery
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 harvesting techniqueThe No-Touch technique focuses on saphenous vein graft harvesting, featured by preserving the surrounding tissue of the vein while at the same time avoiding manual distension. | Procedure or surgery | No-Touch vein harvesting technique |
| Conventional vein harvestingDuring saphenous vein harvesting, surrounding tissue of the vein is stripped off, and manual distension is routinely performed | Procedure or surgery | Conventional vein harvesting |
Primary outcome
Prevalence of graft occlusion
Time frame: 3 month 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.
8 secondary outcomes
Prevalence of graft occlusion
Time frame: 1, 3, 5, 7, and 10 years after procedure
Overall major adverse cardiac or cerebrovascular events (MACCE) rate
Time frame: 3 month , 1, 3, 5, 7, and 10 years after procedure
Cardiac death
Time frame: 3 month , 1, 3, 5, 7, and 10 years after procedure
Documented non-lethal myocardial infarction
Time frame: 3 month , 1, 3, 5, 7, and 10 years after procedure
Stroke
Time frame: 3 month , 1, 3, 5, 7, and 10 years after procedure
Target lesion revascularization
Time frame: 3 month , 1, 3, 5, 7, and 10 years after procedure
Recurrence of Angina
Time frame: 3 month, 1, 3, 5, 7, and 10 years after procedure
Rehospitalization due to cardiac reason
Time frame: 3, 5, 7, and 10 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 4 Oct 2024.
- Background: PubMed 30743210Wang X, Tian M, Zheng Z, Gao H, Wang Y, Wang L, Hu S. Rationale and design of a multicenter randomized trial to compare the graft patency between no-touch vein harvesting technique and conventional approach in coronary artery bypass graft surgery. Am Heart J. 2019 Apr;210:75-80. doi: 10.1016/j.ahj.2018.11.011. Epub 2018 Dec 6.
- Derived from this study: PubMed 40306935Tian M, Wang X, Feng W, Wang H, Liu S, Liu Z, Chen Y, Miao Q, Su P, Li X, Wang Y, Lu B, Chen K, Zhang C, Hu S. No-touch versus conventional vein in coronary artery bypass grafting: three year follow-up of multicentre randomised PATENCY trial. BMJ. 2025 Apr 30;389:e082883. doi: 10.1136/bmj-2024-082883.
- Derived from this study: PubMed 37160216Tian M, Xu B, Chen L, Wu F, Zhang R, Guan C, Xie L, Wang X, Hu S. Outcomes of quantitative flow ratio-based functional incomplete revascularization after coronary artery bypass grafting surgery. J Thorac Cardiovasc Surg. 2024 Aug;168(2):548-558.e13. doi: 10.1016/j.jtcvs.2023.03.032. Epub 2023 May 7.
- Derived from this study: 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.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 harvesting technique and Conventional vein harvesting 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 2 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: under way, not looking for participants, as of the sponsor's last update on 4 Oct 2024. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of graft occlusion (time frame: 3 month 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 NCT03126409, which also lists 4 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 4 Oct 2024.