Investigation of Endothelium in Saphenous Vein Grafts | NCT01510821

Studies
Investigation of Endothelium in Saphenous Vein Grafts

NCT01510821

Sponsor

Emory University

Status

Completed

Last Update Posted

Oct 1, 2013Estimated

Enrollment

30Actual

Phase

Not Applicable

Conditions

Endothelial Function of Saphenous Vein Grafts

Interventions

Use of Maquet Vasoshield Pressure-limiting syringe on SVG
Use of non-regulated syringe on SVG

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2011

Primary Completion Date

Jun 2012Actual

Completion Date

Jun 2012Actual

First Submitted Date

Nov 2, 2011

First Submission Date that Met QC Criteria

Jan 14, 2012

First Posted Date

Jan 18, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 30, 2013

Last Update Posted Date

Oct 1, 2013Estimated

Name	Class
Maquet Cardiovascular	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Maquet Vasoshield Arm	Experimental	Pressure limiting syringe	Other: Use of Maquet Vasoshield Pressure-limiting syringe on SVG
Non-regulated Arm	Active Comparator	standard non-regulated syringe	Other: Use of non-regulated syringe on SVG

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Use of Maquet Vasoshield Pressure-limiting syringe on SVG	Other	Use of Maquet Vasoshield Pressure-limiting syringe on SVG	Maquet Vasoshield Arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
SVG vascular contractility		Day of surgery

Secondary Outcomes

Measure	Description	Time Frame
Nitric oxide metabolite levels		Day of surgery
Major adverse cardiac events		6 months and 1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Vinod Thourani, MD	Emory University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cardiothoracic Surgery Research Laboratory		Atlanta	Georgia	30308	United States
Emory University Hospital Midtown