Coronary Artery DiseaseNCT03729531
Clinical Effect of No-touch Harvesting Technique in OPCABG
A study testing Conventional vein harvesting technique and no-touch vein harvesting technique in people with Coronary Artery Disease and Graft Failure, run by Beijing Anzhen Hospital at 1 site in China.
Trial summary
This study aims to investigate the clinical effect of the new saphenous vein harvesting technique "No-touch" in off-pump coronary artery bypass grafting(OPCABG), comparing to the conventional technique. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Coronary Artery Disease, Graft Failure
- What is being tested?
- Conventional vein harvesting technique and no-touch vein harvesting technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 21 Dec 2018to 1 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients from northern China
- first time isolated off-pump coronary artery bypass graft
- echocardiogram show that ejection fraction is over 35%
- the diameter of saphenous vein ≥ 2mm
- the vein graft will be used in sequential anastomosis, and the anastomosis sites ≥2
- be able to sign informed consent form
Who cannot join
- patients who need to undergo urgent surgery
- Severe renal insufficiency(creatinine >200 umol/L)
- allergic to radiocontrast agent
- vein is used to isolated anastomosis
- Combined with malignant tumor or other severe systemic conditions
Trial locations and contacts
1 site in 1 country.
Kui Zhang, M.D. contact
China1 site, 1 recruiting
- Recruiting
Beijing Anzhen Hospital, Capital medical university
Beijing, Beijing Municipality, 100029
Ju-bing Zheng, M.D.
About this study
Official title: The Clinical Effect of No-touch Vein Harvesting Technique in Off-pump Coronary Artery Bypass Graft
This study aims to investigate the clinical effect of the new saphenous vein harvesting technique "No-touch" in off-pump coronary artery bypass grafting(OPCABG), comparing to the conventional technique. Adopting CTA to evaluate the 3 months patency of the graft, we will compare veins harvested using No-touch technique to saphenous veins using conventional open technique.
Read the detailed description
Coronary artery disease(CAD) is a widespread health issue around the world. It is proven that atherosclerosis is a inflammatory disease, and endothelial dysfunction is one of the key factors that initiates the inflammatory response. Accumulating studies indicate that endothelial homeostasis plays a primordial role in the development of atherosclerosis.
Coronary artery bypass grafting(CABG) is the standard treatment of three-vessel or left main coronary artery disease, and its long-term benefits is apparent. Saphenous vein is the most common graft in CABG, however, the long-term patency is only about 50% in one year, as a result, it is urgent to discover a solution to improve the long term potency of vein grafts.
Conventional harvesting technique dissects the perivascular tissue and inject saline to check leakage, which causes damages to the endothelium of the vein, initiating inflammatory response. No-touch technique is a atraumatic, non-distended harvesting technique. According to the criteria, we will randomize the patients into two groups, the conventional and No-touch group, the vein will be used in sequential anastomosis, by comparing the 3 months patency rate assessed by CTA, we aim to compare the clinical outcomes of the two different vein harvesting techniques.
- Conditions
- Coronary Artery Disease, Graft Failure
- Being tested
- Conventional vein harvesting technique, no-touch vein harvesting technique
- Keywords
- Coronary Artery Disease, Coronary Artery Bypass Grafting, Vein Graft Failure, Endothelial dysfunction
- 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.
Conventional vein harvesting techniqueProcedure or surgery
Long incision will be used to expose the vein, the perivascular tissue will be dissected carefully by scissors, to check for leakage, the vein will be distended by injecting saline.
no-touch vein harvesting techniqueProcedure or surgery
The vein will be harvested by low-frequency electrotome, about 5mm surrounding tissue will be preserved with the vein, distention should be avoided, the vein will not be cut off until being anastomosed.
| Study group | Role | What they receive |
|---|---|---|
| Conventional | Active comparator | The perivascular tissue is stripped off when harvesting the vein, and saline will be used to distend the vein to check for leakage. Receives: Procedure: Conventional vein harvesting technique |
| No-touch | Experimental | The vein will be harvested by frequency electrotome and the perivascular tissue will be preserved, the vein will not be distended. Receives: Procedure: no-touch vein harvesting technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
short-term patency rate of vein grafts
the patency of vein grafts will be assessed by CTA, the doctors of CT department will be masked, at least 2 doctors will provide their conclusions.when the results is controversial, the third doctor will be asked to review the image and provide another conclusion, the patency will be assessed according all results.
Measured: 3 months after surgery
Secondary outcomes (4)
long-term patency rate of vein grafts
the patency will be assessed by CTA the same as short-term patency
Measured: 12 months after surgery
major adverse cardiac and cerebrovascular events(MACCE) rate
all-cause death, myocardial infarction, stroke,repeat revascularizaiton
Measured: 3 months and 12 months after surgery
CCS grade
the grade of angina wii be assessed according to Canadian Cardiovascular Society standard
Measured: 3 months and 12 months after surgery
the healing of the lower leg incision
the healing of the incision will be divided into primary healing, e.g. less tissue defects, neat wound edges, no infection, adhesion or suture to create a tight wound; delayed healing, which means the wound does not closed within 1 month; infection, the wound does not close after 3 months, or necrotic tissues are seen in the incision.
Measured: 3 months and 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2018
- Study start21 Dec 2018
- Primary completion8 Jun 2021 (estimated)
- Study completion1 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 Beijing Anzhen 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Municipal Administration of Hospitals
- Responsible party
- Principal investigator, Zheng Ju-bing, Beijing Anzhen Hospital
- Investigators
- Ju-bing Zheng, M.D., Study director, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03729531
- Sponsor's protocol ID
- PX2018027
- Status last verified
- Jul 2020
- First submitted
- 1 Nov 2018
- Last updated
- 8 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Peng Z, Zhao R, Yang Y, Hua K, Yang X. Predictive Value of the CT-Based Visceral Adiposity Tissue Index and Triglyceride-Glucose Index on New-Onset Atrial Fibrillation after Off-Pump Coronary Artery Bypass Graft: Analyses from a Longitudinal Study. Rev Cardiovasc Med. 2023 Nov 30;24(11):338. doi: 10.31083/j.rcm2411338. eCollection 2023 Nov.
PubMed 39076438
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Effect of No-touch Vein Harvesting Technique in Off-pump Coronary Artery Bypass Graft
- ClinicalTrials.gov ID
- NCT03729531
- Acronym / sponsor ID
- PX2018027
- Conditions
- Coronary Artery Disease, Graft Failure
- Keywords
- Coronary Artery Disease, Coronary Artery Bypass Grafting, Vein Graft Failure, Endothelial dysfunction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Collaborators
- Beijing Municipal Administration of Hospitals
- Study start
- 21 Dec 2018 (actual)
- Primary completion
- 8 Jun 2021 (estimated)
- Study completion
- 1 Jul 2021 (estimated)
- First posted
- 2 Nov 2018 (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 aims to investigate the clinical effect of the new saphenous vein harvesting technique "No-touch" in off-pump coronary artery bypass grafting(OPCABG), comparing to the conventional technique. Adopting CTA to evaluate the 3 months patency of the graft, we will compare veins harvested using No-touch technique to saphenous veins using conventional open technique.
Detailed description
Coronary artery disease(CAD) is a widespread health issue around the world. It is proven that atherosclerosis is a inflammatory disease, and endothelial dysfunction is one of the key factors that initiates the inflammatory response. Accumulating studies indicate that endothelial homeostasis plays a primordial role in the development of atherosclerosis.
Coronary artery bypass grafting(CABG) is the standard treatment of three-vessel or left main coronary artery disease, and its long-term benefits is apparent. Saphenous vein is the most common graft in CABG, however, the long-term patency is only about 50% in one year, as a result, it is urgent to discover a solution to improve the long term potency of vein grafts.
Conventional harvesting technique dissects the perivascular tissue and inject saline to check leakage, which causes damages to the endothelium of the vein, initiating inflammatory response. No-touch technique is a atraumatic, non-distended harvesting technique. According to the criteria, we will randomize the patients into two groups, the conventional and No-touch group, the vein will be used in sequential anastomosis, by comparing the 3 months patency rate assessed by CTA, we aim to compare the clinical outcomes of the two different vein harvesting techniques.
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 |
|---|---|---|
| Conventional | Active comparator | Procedure: Conventional vein harvesting techniqueThe perivascular tissue is stripped off when harvesting the vein, and saline will be used to distend the vein to check for leakage. |
| No-touch | Experimental | Procedure: no-touch vein harvesting techniqueThe vein will be harvested by frequency electrotome and the perivascular tissue will be preserved, the vein will not be distended. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- patients from northern China
- first time isolated off-pump coronary artery bypass graft
- echocardiogram show that ejection fraction is over 35%
- the diameter of saphenous vein ≥ 2mm
- the vein graft will be used in sequential anastomosis, and the anastomosis sites ≥2
Key exclusion criteria (5 listed)
- patients who need to undergo urgent surgery
- Severe renal insufficiency(creatinine >200 umol/L)
- allergic to radiocontrast agent
- vein is used to isolated anastomosis
- Combined with malignant tumor or other severe systemic conditions
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 |
|---|---|---|
| Conventional vein harvesting techniqueLong incision will be used to expose the vein, the perivascular tissue will be dissected carefully by scissors, to check for leakage, the vein will be distended by injecting saline. | Procedure or surgery | Conventional |
| no-touch vein harvesting techniqueThe vein will be harvested by low-frequency electrotome, about 5mm surrounding tissue will be preserved with the vein, distention should be avoided, the vein will not be cut off until being anastomosed. | Procedure or surgery | No-touch |
Primary outcome
short-term patency rate of vein grafts
Time frame: 3 months after surgery
the patency of vein grafts will be assessed by CTA, the doctors of CT department will be masked, at least 2 doctors will provide their conclusions.when the results is controversial, the third doctor will be asked to review the image and provide another conclusion, the patency will be assessed according all results.
4 secondary outcomes
long-term patency rate of vein grafts
Time frame: 12 months after surgery
major adverse cardiac and cerebrovascular events(MACCE) rate
Time frame: 3 months and 12 months after surgery
CCS grade
Time frame: 3 months and 12 months after surgery
the healing of the lower leg incision
Time frame: 3 months and 12 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2020.
- Derived from this study: PubMed 39076438Peng Z, Zhao R, Yang Y, Hua K, Yang X. Predictive Value of the CT-Based Visceral Adiposity Tissue Index and Triglyceride-Glucose Index on New-Onset Atrial Fibrillation after Off-Pump Coronary Artery Bypass Graft: Analyses from a Longitudinal Study. Rev Cardiovasc Med. 2023 Nov 30;24(11):338. doi: 10.31083/j.rcm2411338. eCollection 2023 Nov.
- Individual participant dataSharing planned: Undecided
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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.
Kui Zhang, M.D. contact
Ju-bing Zheng, M.D. study director
Beijing Anzhen Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional vein harvesting technique and no-touch vein harvesting technique in people with Coronary Artery Disease and Graft Failure, run by Beijing Anzhen Hospital 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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 8 Jul 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ju-bing Zheng, M.D. (86-13683113119, zhengjubing@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
short-term patency rate of vein grafts (time frame: 3 months after surgery). 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 NCT03729531, which also lists 1 linked publication.
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 8 Jul 2020.