End Stage Renal DiseasePhase 2NCT00131872
Study to Evaluate the Performance and Safety of Expedial and Compare it to Expanded Polytetrafluoroethylene (ePTFE) Vascular Access Grafts
A Phase 2 study testing Expedial Vascular Access Graft in people with End Stage Renal Disease, run by LeMaitre Vascular at 8 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- Expedial Vascular Access Graft
- Type of treatment
- Medical device
- How many people
- 172 participants
- Where
- 8 sitesUnited States
- Study dates
- Mar 2004to Nov 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
General Surgery
Bamberg, South Carolina, 29003
Vascular Surgery Associates
Baton Rouge, Louisiana, 70809
Duke University Medical Center
Durham, North Carolina, 27710
South Carolina Associates for Cardiac and Vascular Disease; Greenville Hospital System
Greenville, South Carolina, 29605
Vascular and General Surgery
Miami, Florida, 33125
Peripheral Vascular Associates
San Antonio, Texas, 78206
Montefiore Medical Center
The Bronx, New York, 10461
Vascular Surgery
The Bronx, New York, 10461
About this study
Official title: Clinical Study Comparing Expedial and ePTFE Vascular Access Grafts
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
- Being tested
- Expedial Vascular Access Graft
- Keywords
- vascular access graft, hemodialysis, dialysis, end stage renal disease
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expedial Vascular Access GraftDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2005 (estimated)
- Study startMar 2004
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 172 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LeMaitre Vascular
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00131872
- Sponsor's protocol ID
- 00168
- Status last verified
- Nov 2006
- First submitted
- 17 Aug 2005
- Last updated
- 8 Jul 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study Comparing Expedial and ePTFE Vascular Access Grafts
- ClinicalTrials.gov ID
- NCT00131872
- Acronym / sponsor ID
- 00168
- Conditions
- End Stage Renal Disease
- Keywords
- vascular access graft, hemodialysis, dialysis, end stage renal disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 172 participants (estimated)
- Lead sponsor
- LeMaitre VascularIndustry (pharma, biotech, devices)
- Study start
- Mar 2004
- Study completion
- Nov 2006 (actual)
- First posted
- 19 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Expedial Vascular Access Graft | Device | – |
Primary outcome
Primary or assisted primary patency at 1 year
4 secondary outcomes
Secondary patency
Overall adverse event rate
Time to first access
Time to hemostasis following needle withdrawal after dialysis
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Expedial Vascular Access Graft in people with End Stage Renal Disease, run by LeMaitre Vascular at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary or assisted primary patency at 1 year. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2024.