Skip to content

Investigation of Endothelium in Saphenous Vein Grafts

A Prospective Trial to Investigate Endothelial Dysfunction in Saphenous Vein Grafts Subjected to the Maquet Vasoshield Pressure Limiting Syringe Versus Non-Regulated Vessel Dilation in Patients Undergoing Coronary Artery Bypass Grafting

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01510821
Enrollment
30
Registered
2012-01-18
Start date
2011-11-30
Completion date
2012-06-30
Last updated
2013-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endothelial Function of Saphenous Vein Grafts

Keywords

endoscopic vein harvest, saphenous vein graft, endothelial function

Brief summary

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.

Interventions

OTHERUse of Maquet Vasoshield Pressure-limiting syringe on SVG

Use of Maquet Vasoshield Pressure-limiting syringe on SVG

OTHERUse of non-regulated syringe on SVG

Use of non-regulated syringe on SVG

Sponsors

Maquet Cardiovascular
CollaboratorINDUSTRY
Emory University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
SVG vascular contractilityDay of surgery

Secondary

MeasureTime frame
Nitric oxide metabolite levelsDay of surgery
Major adverse cardiac events6 months and 1 year

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026