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Investigation of Endothelium in Saphenous Vein Grafts

NCT01510821 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2013-10-01

No results posted yet for this study

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.

Conditions

  • Endothelial Function of Saphenous Vein Grafts

Interventions

OTHER

Use of Maquet Vasoshield Pressure-limiting syringe on SVG

Use of Maquet Vasoshield Pressure-limiting syringe on SVG

OTHER

Use of non-regulated syringe on SVG

Use of non-regulated syringe on SVG

Sponsors & Collaborators

  • Maquet Cardiovascular

    collaborator INDUSTRY

  • Emory University

    lead OTHER

Principal Investigators

  • Vinod Thourani, MD · Emory University

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01510821 on ClinicalTrials.gov