Clinical trial NCT03729531: Clinical Effect of No-touch Harvesting Technique in OPCABG
Official title: The Clinical Effect of No-touch Vein Harvesting Technique in Off-pump Coronary Artery Bypass Graft
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Disease
Graft Failure
Keywords: Coronary Artery Disease
Coronary Artery Bypass Grafting
Vein Graft Failure
Endothelial dysfunction
Lead sponsor: Beijing Anzhen Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Municipal Administration of Hospitals
First posted: 2018-11-02
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: short-term patency rate of vein grafts
timeFrame: 3 months after surgery
Secondary outcomes:
measure: long-term patency rate of vein grafts
timeFrame: 12 months after surgery
measure: major adverse cardiac and cerebrovascular events(MACCE) rate
timeFrame: 3 months and 12 months after surgery
measure: CCS grade
timeFrame: 3 months and 12 months after surgery
measure: the healing of the lower leg incision
timeFrame: 3 months and 12 months after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital, Capital medical university
state: Beijing
Study officials:
affiliation: Beijing Anzhen Hospital
name: Ju-bing Zheng, M.D.
role: STUDY_DIRECTOR
References: