Clinical Effect of No-touch Harvesting Technique in OPCABG
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|ClinicalTrials.gov Identifier: NCT03729531|
Recruitment Status : Recruiting
First Posted : November 2, 2018
Last Update Posted : July 8, 2020
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease Graft Failure||Procedure: Conventional vein harvesting technique Procedure: no-touch vein harvesting technique||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||The Clinical Effect of No-touch Vein Harvesting Technique in Off-pump Coronary Artery Bypass Graft|
|Actual Study Start Date :||December 21, 2018|
|Estimated Primary Completion Date :||June 8, 2021|
|Estimated Study Completion Date :||July 1, 2021|
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.
Procedure: Conventional vein harvesting technique
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.
The vein will be harvested by frequency electrotome and the perivascular tissue will be preserved, the vein will not be distended.
Procedure: no-touch vein harvesting technique
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.
- 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.
- long-term patency rate of vein grafts [ Time Frame: 12 months after surgery ]the patency will be assessed by CTA the same as short-term patency
- major adverse cardiac and cerebrovascular events(MACCE) rate [ Time Frame: 3 months and 12 months after surgery ]all-cause death, myocardial infarction, stroke,repeat revascularizaiton
- CCS grade [ Time Frame: 3 months and 12 months after surgery ]the grade of angina wii be assessed according to Canadian Cardiovascular Society standard
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03729531
|Contact: Ju-bing Zheng, M.D.||firstname.lastname@example.org|
|Contact: Kui Zhang, M.D.||86-15001178663|
|Beijing Anzhen Hospital, Capital medical university||Recruiting|
|Beijing, Beijing, China, 100029|
|Contact: Ju-bing Zheng, M.D.|
|Study Director:||Ju-bing Zheng, M.D.||Beijing Anzhen Hospital|