Investigation of Endothelium in Saphenous Vein Grafts

Emory University

Status: Completed

Conditions: Endothelial Function of Saphenous Vein Grafts

Treatments: Other: Use of Maquet Vasoshield Pressure-limiting syringe on SVG; Other: Use of non-regulated syringe on SVG

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01510821

IRB00049331

Details and patient eligibility

About

This is a single center prospective study of 30 patients undergoing elective heart bypass surgery (CABG) with at least two vein grafts from the leg (SVG). The purpose of this ex vivo study is to evaluate the function of vein grafts from small tissue samples treated with a pressure syringe and a non-pressure syringe. Syringes are routinely used to flush out the veins in preparation of bypass grafting. It is unknown if different levels of pressure in the syringe affect the vein or damage the vein. Small sections of tissue samples which are normally discarded will be obtained immediately after retrieval from the leg and before grafting to the heart. Tissue samples will be taken to the laboratory for study. There are no clinical endpoints in this study, however, clinical information will be obtained from the Society of Thoracic Surgeons database and will include demographics, risk factors, and perioperative outcomes.

Enrollment: 30 patients

Sex: All

Ages: 21 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients undergoing elective coronary artery bypass graft surgery requiring at least 2 saphenous vein grafts

Exclusion criteria

• patients undergoing any concomitant surgical procedures

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Maquet Vasoshield Arm

Experimental group

Description:

Pressure limiting syringe

Treatment:

Other: Use of Maquet Vasoshield Pressure-limiting syringe on SVG

Non-regulated Arm

Active Comparator group

Description:

standard non-regulated syringe

Treatment:

Other: Use of non-regulated syringe on SVG