Clinical Effect of No-touch Harvesting Technique in OPCABG

Not Applicable

• Conditions: Coronary Artery Disease; Graft Failure
• Interventions: Procedure: Conventional vein harvesting technique; Procedure: no-touch vein harvesting technique

• Registration Number: NCT03729531
• Lead Sponsor: Beijing Anzhen Hospital

Brief 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.

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 Timeline

• Study First Submitted: 2018-11-01
• Study First Submitted QC: 2018-11-01
• Study First Posted: 2018-11-02
• Study Start: 2018-12-21
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-06
• Last Update Posted: 2020-07-08
• Primary Completion: 2021-06-08
• Study Completion: 2021-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional	Conventional vein harvesting technique	The perivascular tissue is stripped off when harvesting the vein, and saline will be used to distend the vein to check for leakage.
No-touch	no-touch vein harvesting technique	The vein will be harvested by frequency electrotome and the perivascular tissue will be preserved, the vein will not be distended.

Primary Outcome Measures

Name	Time	Method
short-term patency rate of vein grafts	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.

Secondary Outcome Measures

Name	Time	Method
CCS grade	3 months and 12 months after surgery	the grade of angina wii be assessed according to Canadian Cardiovascular Society standard
major adverse cardiac and cerebrovascular events(MACCE) rate	3 months and 12 months after surgery	all-cause death, myocardial infarction, stroke,repeat revascularizaiton
long-term patency rate of vein grafts	12 months after surgery	the patency will be assessed by CTA the same as short-term patency
the healing of the lower leg incision	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.

Trial Locations

Locations (1)

Beijing Anzhen Hospital, Capital medical university; 🇨🇳 Beijing, Beijing, China