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

End Stage Renal Disease Clinical Trial

Official title:

Clinical Study Comparing Expedial and ePTFE Vascular Access Grafts

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00131872
• Other study ID #: 00168
• Status: Terminated
• Phase: Phase 2
• First received: August 17, 2005
• Last updated: January 24, 2008
• Start date: March 2004
• Est. completion date: November 2006

Study information

• Verified date: November 2006
• Source: LeMaitre Vascular
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 172
• Est. completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

Device:
• Expedial Vascular Access Graft

Locations

Country	Name	City	State
United States	General Surgery	Bamberg	South Carolina
United States	Vascular Surgery Associates	Baton Rouge	Louisiana
United States	Montefiore Medical Center	Bronx	New York
United States	Vascular Surgery	Bronx	New York
United States	Duke University Medical Center	Durham	North Carolina
United States	South Carolina Associates for Cardiac and Vascular Disease; Greenville Hospital System	Greenville	South Carolina
United States	Vascular and General Surgery	Miami	Florida
United States	Peripheral Vascular Associates	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
LeMaitre Vascular

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary or assisted primary patency at 1 year
Secondary	Secondary patency
Secondary	Overall adverse event rate
Secondary	Time to first access
Secondary	Time to hemostasis following needle withdrawal after dialysis