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Study to Evaluate the Performance and Safety of Expedial and Compare it to Expanded Polytetrafluoroethylene (ePTFE) Vascular Access Grafts

Primary Purpose

End Stage Renal Disease

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Expedial Vascular Access Graft
Sponsored by
LeMaitre Vascular
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for End Stage Renal Disease focused on measuring vascular access graft, hemodialysis, dialysis, end stage renal disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patient has chronic renal failure and requires vascular access for hemodialysis Patient has given informed consent to participate in the trial and is willing to comply with the study protocol Patient is male or female, 18 years of age or older The vascular access graft can be placed in the upper extremity (forearm, including across the elbow, or upper arm) Patient is undergoing or will undergo hemodialysis at a hospital or hemodialysis center Patient has a vein 4 mm or larger to which the graft can be anastomosed Exclusion Criteria: Patient is unable to comply with the study follow-up Patient has a known sensitivity to polyurethane or porcine heparin Patient has a previous vascular access graft implanted and it is not possible to place the study graft proximal to the existing device and no other sites are available Patient has an immunodeficiency syndrome Patient has a prior history of bacterial infection within 8 weeks of implantation of graft Patient has a severe coagulation disorder Patient has an elevated platelet count of greater than 1 million Patient has a history of heparin-induced thrombocytopenia syndrome (HIT) Patient is pregnant Patient has a fever greater than 100 degrees Fahrenheit

Sites / Locations

  • Vascular and General Surgery
  • Vascular Surgery Associates
  • Montefiore Medical Center
  • Vascular Surgery
  • Duke University Medical Center
  • General Surgery
  • South Carolina Associates for Cardiac and Vascular Disease; Greenville Hospital System
  • Peripheral Vascular Associates

Outcomes

Primary Outcome Measures

Primary or assisted primary patency at 1 year

Secondary Outcome Measures

Secondary patency
Overall adverse event rate
Time to first access
Time to hemostasis following needle withdrawal after dialysis

Full Information

First Posted
August 17, 2005
Last Updated
January 24, 2008
Sponsor
LeMaitre Vascular
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1. Study Identification

Unique Protocol Identification Number
NCT00131872
Brief Title
Study to Evaluate the Performance and Safety of Expedial and Compare it to Expanded Polytetrafluoroethylene (ePTFE) Vascular Access Grafts
Official Title
Clinical Study Comparing Expedial and ePTFE Vascular Access Grafts
Study Type
Interventional

2. Study Status

Record Verification Date
November 2006
Overall Recruitment Status
Terminated
Study Start Date
March 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
LeMaitre Vascular

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to establish the substantial equivalence of Expedial and ePTFE grafts for effectiveness in maintaining primary or assisted primary patency.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease
Keywords
vascular access graft, hemodialysis, dialysis, end stage renal disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
172 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Expedial Vascular Access Graft
Primary Outcome Measure Information:
Title
Primary or assisted primary patency at 1 year
Secondary Outcome Measure Information:
Title
Secondary patency
Title
Overall adverse event rate
Title
Time to first access
Title
Time to hemostasis following needle withdrawal after dialysis

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient has chronic renal failure and requires vascular access for hemodialysis Patient has given informed consent to participate in the trial and is willing to comply with the study protocol Patient is male or female, 18 years of age or older The vascular access graft can be placed in the upper extremity (forearm, including across the elbow, or upper arm) Patient is undergoing or will undergo hemodialysis at a hospital or hemodialysis center Patient has a vein 4 mm or larger to which the graft can be anastomosed Exclusion Criteria: Patient is unable to comply with the study follow-up Patient has a known sensitivity to polyurethane or porcine heparin Patient has a previous vascular access graft implanted and it is not possible to place the study graft proximal to the existing device and no other sites are available Patient has an immunodeficiency syndrome Patient has a prior history of bacterial infection within 8 weeks of implantation of graft Patient has a severe coagulation disorder Patient has an elevated platelet count of greater than 1 million Patient has a history of heparin-induced thrombocytopenia syndrome (HIT) Patient is pregnant Patient has a fever greater than 100 degrees Fahrenheit
Facility Information:
Facility Name
Vascular and General Surgery
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
Vascular Surgery Associates
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Vascular Surgery
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
General Surgery
City
Bamberg
State/Province
South Carolina
ZIP/Postal Code
29003
Country
United States
Facility Name
South Carolina Associates for Cardiac and Vascular Disease; Greenville Hospital System
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Peripheral Vascular Associates
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78206
Country
United States

12. IPD Sharing Statement

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Study to Evaluate the Performance and Safety of Expedial and Compare it to Expanded Polytetrafluoroethylene (ePTFE) Vascular Access Grafts

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