Clinical Effect of No-touch Harvesting Technique in OPCABG

Capital Medical University

Status: Unknown

Conditions: Graft Failure; Coronary Artery Disease

Treatments: Procedure: Conventional vein harvesting technique; Procedure: no-touch vein harvesting technique

Study type: Interventional

Funder types: Other

Identifiers

NCT03729531

PX2018027

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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200 participants in 2 patient groups

Conventional

Active Comparator group

Description:

The perivascular tissue is stripped off when harvesting the vein, and saline will be used to distend the vein to check for leakage.

Treatment:

Procedure: Conventional vein harvesting technique

No-touch

Experimental group

Description:

The vein will be harvested by frequency electrotome and the perivascular tissue will be preserved, the vein will not be distended.

Treatment:

Procedure: no-touch vein harvesting technique