Suspended
Clinical Study Comparing Expedial and ePTFE Vascular Access Grafts
What is being tested
Data Collection
Who is being recruted
Urogenital Diseases+10
+ Chronic Disease
+ Female Urogenital Diseases and Pregnancy Complications
Over 18 Years
+16 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 2
Interventional
Study Start: March 2004
Summary
Principal SponsorLeMaitre Vascular
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: March 1, 2004
Actual date on which the first participant was enrolled.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.
Official TitleClinical Study Comparing Expedial and ePTFE Vascular Access Grafts
Principal SponsorLeMaitre Vascular
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
172 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Urogenital DiseasesChronic DiseaseFemale Urogenital Diseases and Pregnancy ComplicationsKidney DiseasesKidney Failure, ChronicPathologic ProcessesPathological Conditions, Signs and SymptomsUrologic DiseasesDisease AttributesRenal Insufficiency, ChronicRenal InsufficiencyFemale Urogenital DiseasesMale Urogenital Diseases
Criteria
6 inclusion criteria required to participate
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)
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10 exclusion criteria prevent from participating
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
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Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 8 locations
Suspended
Suspended
Vascular Surgery Associates
Baton Rouge, United StatesSuspended
Montefiore Medical Center
The Bronx, United StatesSuspended
Vascular Surgery
The Bronx, United StatesSuspended8 Study Centers