An interventional study of Conventional vein harvesting technique and no-touch vein harvesting technique in Coronary Artery Disease and Graft Failure, sponsored by Beijing Anzhen Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-07-08.
Sponsored by Beijing Anzhen Hospital · Not applicable, Interventional, and Treatment
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.
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.
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's planned enrollment of 200 is above the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.
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Exclusion Criteria:
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
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
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 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
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.
Time frame: 3 months after surgery
long-term patency rate of vein grafts
the patency will be assessed by CTA the same as short-term patency
Time frame: 12 months after surgery
major adverse cardiac and cerebrovascular events(MACCE) rate
all-cause death, myocardial infarction, stroke,repeat revascularizaiton
Time frame: 3 months and 12 months after surgery
CCS grade
the grade of angina wii be assessed according to Canadian Cardiovascular Society standard
Time frame: 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.
Time frame: 3 months and 12 months after surgery
Plan to share: Undecided
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This study is status unknown, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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Beijing Anzhen Hospital