- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03729531
Clinical Effect of No-touch Harvesting Technique in OPCABG
The Clinical Effect of No-touch Vein Harvesting Technique in Off-pump Coronary Artery Bypass Graft
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ju-bing Zheng, M.D.
- Phone Number: 86-13683113119
- Email: zhengjubing@hotmail.com
Study Contact Backup
- Name: Kui Zhang, M.D.
- Phone Number: 86-15001178663
Study Locations
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Beijing
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Beijing, Beijing, China, 100029
- Recruiting
- Beijing Anzhen Hospital, Capital Medical University
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Contact:
- Ju-bing Zheng, M.D.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Conventional
The perivascular tissue is stripped off when harvesting the vein, and saline will be used to distend the vein to check for leakage.
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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.
|
Experimental: No-touch
The vein will be harvested by frequency electrotome and the perivascular tissue will be preserved, the vein will not be distended.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
3 months after surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
long-term patency rate of vein grafts
Time Frame: 12 months after surgery
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the patency will be assessed by CTA the same as short-term patency
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12 months after surgery
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major adverse cardiac and cerebrovascular events(MACCE) rate
Time Frame: 3 months and 12 months after surgery
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all-cause death, myocardial infarction, stroke,repeat revascularizaiton
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3 months and 12 months after surgery
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CCS grade
Time Frame: 3 months and 12 months after surgery
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the grade of angina wii be assessed according to Canadian Cardiovascular Society standard
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3 months and 12 months after surgery
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the healing of the lower leg incision
Time Frame: 3 months and 12 months after surgery
|
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.
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3 months and 12 months after surgery
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Ju-bing Zheng, M.D., Beijing Anzhen Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PX2018027
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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