Comparison of Saphenous Vein Harvesting by Endoscopic Versus Open Conventional Methods
Coronary Artery Disease
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring Vein graft
Eligibility Criteria
Inclusion Criteria:
- Male or female patients over the age of 18;
- Patients with ischemic heart disease who are planned to undergo CABG surgery;
- A vein graft in necessary for the revascularization;
- There is no indication for one specific method for vein harvesting;
- Informed consent obtained.
Exclusion Criteria:
- Patients who undergo a non-elective surgery
- Concomitant procedures during the CABG surgery;
- Any known infection in the past 6 months;
- Evidence of vein thrombosis in an ultrasound study prior to surgery;
- Morbid obesity patients;
- Patients with peripheral vascular disease;
- Patients who would gain from one technique more than the other by any reason (according to the surgeon or investigator opinion);
- Severe primary mitral and aortic valve stenosis or regurgitation;
- Patients who have undergone a previous cardiac surgery from any kind;
- Patients who underwent any surgery in the lower extremities in the past (i.e. orthopedic, vascular, etc.);
- Any serious disease likely to interfere with the conduct of the study;
- Participation in other clinical trial;
- Patients geographically not stable or unavailable for follow-up.
Sites / Locations
- Sheba Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Open vein harvest
Endoscopic vein harvest
For the standard open conventional technique, the saphenous vein will be exposed by a longitudinal leg incision starting from the medial malleolus and ending at the upper medial thigh at the sapheno-femoral junction. The saphenous vein will be dissected free from its perivascular fat pedicle and visible side branches will be ligated and divided.
We will use the Terumo VirtuoSaph® Plus Endoscopic Vessel Harvesting System for all endoscopic vein extractions, which is an open carbon dioxide (CO2) system. Approximately 6 l/min of CO2 will be continuously insufflated in the subcutaneous tunnel.