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

NCT00131872 | Terminated Phase 2

• 1 other identifier: 00168
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 8

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.

Conditions

End Stage Renal Disease

Keywords

vascular access graft; hemodialysis; dialysis; end stage renal disease

Outcome Measures

Primary Outcomes (1)

• Primary or assisted primary patency at 1 year

Secondary Outcomes (4)

• Secondary patency

• Overall adverse event rate

• Time to first access

• Time to hemostasis following needle withdrawal after dialysis

Interventions

Expedial Vascular Access Graft DEVICE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• LeMaitre Vascular: lead

Study Sites (8)

Vascular and General Surgery

Miami, Florida, 33125, United States

Location

Vascular Surgery Associates

Baton Rouge, Louisiana, 70809, United States

Location

Montefiore Medical Center

The Bronx, New York, 10461, United States

Location

Vascular Surgery

The Bronx, New York, 10461, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

General Surgery

Bamberg, South Carolina, 29003, United States

Location

South Carolina Associates for Cardiac and Vascular Disease; Greenville Hospital System

Greenville, South Carolina, 29605, United States

Location

Peripheral Vascular Associates

San Antonio, Texas, 78206, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 17, 2005
• First Posted: August 19, 2005
• Study Start: March 1, 2004
• Study Completion: November 1, 2006
• Last Updated: July 8, 2024

Record last verified: 2006-11

Locations

US (8)