Clinical Effect of No-touch Harvesting Technique in OPCABG

Coronary Artery Disease Clinical Trial

Official title:

The Clinical Effect of No-touch Vein Harvesting Technique in Off-pump Coronary Artery Bypass Graft

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03729531
• Other study ID #: PX2018027
• Status: Recruiting
• Phase: N/A
• Start date: December 21, 2018
• Est. completion date: July 1, 2021

Study information

• Verified date: July 2020
• Source: Beijing Anzhen Hospital
• Contact: Ju-bing Zheng, M.D.
• Phone: 86-13683113119
• Email: zhengjubing[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 1, 2021
• Est. primary completion date: June 8, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Graft Failure
• Myocardial Ischemia

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Beijing Anzhen Hospital, Capital medical university	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Beijing Anzhen Hospital	Beijing Municipal Administration of Hospitals

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months after surgery
Secondary	long-term patency rate of vein grafts	the patency will be assessed by CTA the same as short-term patency	12 months after surgery
Secondary	major adverse cardiac and cerebrovascular events(MACCE) rate	all-cause death, myocardial infarction, stroke,repeat revascularizaiton	3 months and 12 months after surgery
Secondary	CCS grade	the grade of angina wii be assessed according to Canadian Cardiovascular Society standard	3 months and 12 months after surgery
Secondary	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.	3 months and 12 months after surgery