End Stage Renal DiseasePhase 2/3ACUSEALNCT01173718
Evaluation of the GORE® ACUSEAL Vascular Graft for Hemodialysis Access
A Phase 2/3 study testing GORE® ACUSEAL Vascular Graft in people with End Stage Renal Disease, run by W.L.Gore & Associates.
Trial summary
This study is a prospective, non-randomized, multi-center evaluation of the performance of the GORE® ACUSEAL Vascular Graft. The study will enroll patients with End-Stage Renal Disease (ESRD), who are either currently receiving or expected to require hemodialysis through a prosthetic vascular graft within 30 days. 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?
- GORE® ACUSEAL Vascular Graft
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- No sites listed yet
- Study dates
- Jul 2010to Feb 2013
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 requires the creation of a vascular access graft for hemodialysis secondary to a diagnosis of End-Stage Renal Disease. >
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- Patient is currently on hemodialysis or ready to begin hemodialysis within 30 days following placement of study device. > >>
- The patient must be able to have the vascular access graft placed in an upper extremity. >
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- The patient is 18 years of age or older. >
Show all 49Show fewer
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- The patient has a reasonable expectation of remaining on hemodialysis for 12 months. >
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- The patient or his/her legal guardian understands the study and is willing and able to comply with follow-up requirements. > >>
- The patient or his/her legal guardian is willing to provide informed consent. >
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- >
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- >
- >> Exclusion Criteria:>
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- The patient has a documented and unsuccessfully treated ipsilateral central venous stenosis via imaging technique.>
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- The patient currently has a known or suspected systemic infection.>
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- The patient has a known hypercoagulable or bleeding disorder or requires treatment with warfarin or heparin.>
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- The patient has had a previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or has known sensitivity to heparin. >
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- The patient is being considered for a live (living donor either related or unrelated to patient) donor kidney transplant.>
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- The patient is enrolled in another investigational study.>
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- The patient has co-morbid conditions that may limit their ability to comply with study and follow-up requirements.>
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- Study device is intended to be used temporarily.>
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- The patient has had >2 previous arteriovenous accesses in treatment arm.>
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- Patient is taking Aggrenox®.>
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- The patient is in need of, or is scheduled for a different vascular surgical procedure within 30 days of the study procedure.>
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- The patient is currently taking maintenance immunosuppressant medication such as rapamycin, mycophenolate or mycophenolic acid, prednisone(>10 mg), cyclosporine, tacrolimus or cyclophosphamide.>
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- The patient has a known hypercoagulable or bleeding disorder or requires treatment with warfarin or heparin.>
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- Life expectancy is less than 12 months.>
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- The patient is pregnant.>
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- The patient is a poor compliance risk (i.e. history of IV or oral drug abuse).
Who cannot join
None listed.
About this study
Official title: Evaluation of the GORE® ACUSEAL Vascular Graft for Hemodialysis Access (ACUSEAL, AVG 08-06)
This study is a prospective, non-randomized, multi-center evaluation of the performance of the GORE® ACUSEAL Vascular Graft. The study will enroll patients with End-Stage Renal Disease (ESRD), who are either currently receiving or expected to require hemodialysis through a prosthetic vascular graft within 30 days. Gore proposes to demonstrate that the 6 month cumulative patency of the GORE® ACUSEAL Vascular Graft is similar to that of other arteriovenous grafts (AVGs). > >>
>
Read more
>> A total of 138 Subjects will be enrolled. Once the study procedure has been successfully completed, cannulation may occur at any time at the Investigator's discretion. >
>>
>
>> Subjects will be selected from up to 20 Investigational Sites.
- Conditions
- End Stage Renal Disease
- Being tested
- GORE® ACUSEAL Vascular Graft
- Keywords
- Hemodialysis, Vascular Graft
- 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.
GORE® ACUSEAL Vascular GraftDevice
Surgical implantation of the GORE® ACUSEAL Vascular Graft for Hemodialysis per the Investigator's standard of practice.
| Study group | Role | What they receive |
|---|---|---|
| GORE® ACUSEAL Vascular Graft | Experimental | Not described Receives: Device: GORE® ACUSEAL Vascular Graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative Patency at 6 Months
Percentage of subjects free from loss of access for hemodialysis at the study access site, assessed at 6 month.
Measured: 6 Months
Freedom From Bleeding at 6 Months
Percentage of subjects free from both major and minor bleeding events, assessed at 6-months
Measured: 6 Months
Secondary outcomes (4)
Primary Unassisted Patency at 6 Months
The primary unassisted patency is defined as the percentage of subjects free from the first occurence of either access thrombosis or an access procedure performed to maintain access patency.
Measured: 6 Months
Time to Event Analysis (Cumulative Patency)
The cumulative patency at 6 months and time-to-loss of cumulative patency will be estimated using the Kaplan-Meier survival curve for time-to-event analysis to obtain estimates accounting for censoring.
Measured: 6 Months
Time to First Cannulation
The time to first cannulation is defined as the time from access placement to the first cannulation of the GORE® ACUSEAL Vascular Graft.
Measured: Time of access placement to first cannulation, assessed up to one week
Time to Potential Central Venous Catheter Removal
The time to potential central venous catheter removal is defined as the time from the initial study procedure to the third consecutive cannulation through the GORE® ACUSEAL Vascular Graft in which hemodialysis is carried out. The third consecutive cannulation is a surrogate endpoint for time to CVC removal. Typically, CVC removal is ordered after the third consecutive cannulation.
Measured: Initial study procedure to the third consecutive cannulation, assessed from day 3 thru day 123
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2010 (estimated)
- Study startJul 2010
- Primary completionSep 2012
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by W.L.Gore & AssociatesThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- W.L.Gore & Associates
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marc Glickman, MD, Principal investigator, Sentara Vascular Specialists
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01173718
- Sponsor's protocol ID
- AVG 08-06
- Acronym
- ACUSEAL
- Status last verified
- Jul 2013
- First submitted
- 29 Jul 2010
- Last updated
- 26 Jul 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Glickman MH, Burgess J, Cull D, Roy-Chaudhury P, Schanzer H. Prospective multicenter study with a 1-year analysis of a new vascular graft used for early cannulation in patients undergoing hemodialysis. J Vasc Surg. 2015 Aug;62(2):434-41. doi: 10.1016/j.jvs.2015.03.020. Epub 2015 May 4.
PubMed 25953016
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the GORE® ACUSEAL Vascular Graft for Hemodialysis Access (ACUSEAL, AVG 08-06)
- ClinicalTrials.gov ID
- NCT01173718
- Acronym / sponsor ID
- ACUSEAL / AVG 08-06
- Conditions
- End Stage Renal Disease
- Keywords
- Hemodialysis, Vascular Graft
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- W.L.Gore & AssociatesIndustry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Sep 2012 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 2 Aug 2010 (estimated)
- Results
- Posted 2 Jul 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a prospective, non-randomized, multi-center evaluation of the performance of the GORE® ACUSEAL Vascular Graft. The study will enroll patients with End-Stage Renal Disease (ESRD), who are either currently receiving or expected to require hemodialysis through a prosthetic vascular graft within 30 days. Gore proposes to demonstrate that the 6 month cumulative patency of the GORE® ACUSEAL Vascular Graft is similar to that of other arteriovenous grafts (AVGs). > >>
>
>> A total of 138 Subjects will be enrolled. Once the study procedure has been successfully completed, cannulation may occur at any time at the Investigator's discretion. >
>>
>
>> Subjects will be selected from up to 20 Investigational Sites.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GORE® ACUSEAL Vascular Graft | Experimental | Device: GORE® ACUSEAL Vascular Graft |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (49 listed)
- Patient requires the creation of a vascular access graft for hemodialysis secondary to a diagnosis of End-Stage Renal Disease. >
- >>
- Patient is currently on hemodialysis or ready to begin hemodialysis within 30 days following placement of study device. > >>
- The patient must be able to have the vascular access graft placed in an upper extremity. >
- >>
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| GORE® ACUSEAL Vascular GraftSurgical implantation of the GORE® ACUSEAL Vascular Graft for Hemodialysis per the Investigator's standard of practice. | Device | GORE® ACUSEAL Vascular Graft |
Primary outcome
Cumulative Patency at 6 Months
Time frame: 6 Months
Percentage of subjects free from loss of access for hemodialysis at the study access site, assessed at 6 month.
Freedom From Bleeding at 6 Months
Time frame: 6 Months
Percentage of subjects free from both major and minor bleeding events, assessed at 6-months
4 secondary outcomes
Primary Unassisted Patency at 6 Months
Time frame: 6 Months
Time to Event Analysis (Cumulative Patency)
Time frame: 6 Months
Time to First Cannulation
Time frame: Time of access placement to first cannulation, assessed up to one week
Time to Potential Central Venous Catheter Removal
Time frame: Initial study procedure to the third consecutive cannulation, assessed from day 3 thru day 123
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25953016Glickman MH, Burgess J, Cull D, Roy-Chaudhury P, Schanzer H. Prospective multicenter study with a 1-year analysis of a new vascular graft used for early cannulation in patients undergoing hemodialysis. J Vasc Surg. 2015 Aug;62(2):434-41. doi: 10.1016/j.jvs.2015.03.020. Epub 2015 May 4.
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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.
Marc Glickman, MD principal investigator
Sentara Vascular Specialists
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing GORE® ACUSEAL Vascular Graft in people with End Stage Renal Disease, run by W.L.Gore & Associates.
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 49 inclusion and 0 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: finished, as of the sponsor's last update on 26 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jul 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Cumulative Patency at 6 Months (time frame: 6 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01173718, which also lists 1 linked publication.
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 26 Jul 2013.