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Investigation of Endothelium in Saphenous Vein Grafts

NCT ID: NCT01510821

Last Updated: 2013-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2012-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Endothelial Function of Saphenous Vein Grafts

Keywords

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endoscopic vein harvest saphenous vein graft endothelial function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Maquet Vasoshield Arm

Pressure limiting syringe

Group Type EXPERIMENTAL

Use of Maquet Vasoshield Pressure-limiting syringe on SVG

Intervention Type OTHER

Use of Maquet Vasoshield Pressure-limiting syringe on SVG

Non-regulated Arm

standard non-regulated syringe

Group Type ACTIVE_COMPARATOR

Use of non-regulated syringe on SVG

Intervention Type OTHER

Use of non-regulated syringe on SVG

Interventions

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Use of Maquet Vasoshield Pressure-limiting syringe on SVG

Use of Maquet Vasoshield Pressure-limiting syringe on SVG

Intervention Type OTHER

Use of non-regulated syringe on SVG

Use of non-regulated syringe on SVG

Intervention Type OTHER

Other Intervention Names

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Maquet device standard syringe

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Maquet Cardiovascular

INDUSTRY

Sponsor Role collaborator

Emory University

OTHER

Sponsor Role lead

Responsible Party

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Vinod Thourani

Associate Professor of Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vinod Thourani, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

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Cardiothoracic Surgery Research Laboratory

Atlanta, Georgia, United States

Site Status

Emory University Hospital Midtown

Atlanta, Georgia, United States

Site Status

Countries

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United States

Other Identifiers

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IRB00049331

Identifier Type: -

Identifier Source: org_study_id