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CompletedNCT01173718ACUSEALUpdated Jul 26, 2013Results posted

Evaluation of the GORE® ACUSEAL Vascular Graft for Hemodialysis Access

A Phase 2/3 interventional study of GORE® ACUSEAL Vascular Graft in End Stage Renal Disease, sponsored by W.L.Gore & Associates. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-07-26.

Sponsored by W.L.Gore & Associates · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
138
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study 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. 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). > >>

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>> 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. >

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>> Subjects will be selected from up to 20 Investigational Sites.

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Conditions studied

  • End Stage Renal Disease

Keywords

  • Hemodialysis
  • Vascular Graft
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In context

Kidney Failure, Chronic

2,085 studies on the registry are indexed under Kidney Failure, Chronic; 260 are open to participants now.

This study's enrollment of 138 is above the median of 55 across 1,557 interventional studies indexed under Kidney Failure, Chronic.

Browse Kidney Failure, Chronic studies →

Lead sponsor

W.L.Gore & Associates is the lead sponsor of 95 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:>

  1. Patient requires the creation of a vascular access graft for hemodialysis secondary to a diagnosis of End-Stage Renal Disease. >

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  2. Patient is currently on hemodialysis or ready to begin hemodialysis within 30 days following placement of study device. > >>

  3. The patient must be able to have the vascular access graft placed in an upper extremity. >

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  4. The patient is 18 years of age or older. >

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  5. The patient has a reasonable expectation of remaining on hemodialysis for 12 months. >

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  6. The patient or his/her legal guardian understands the study and is willing and able to comply with follow-up requirements. > >>

  7. 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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  1. The patient has a documented and unsuccessfully treated ipsilateral central venous stenosis via imaging technique.>

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  2. The patient currently has a known or suspected systemic infection.>

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  3. The patient has a known hypercoagulable or bleeding disorder or requires treatment with warfarin or heparin.>

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  4. 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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  5. The patient is being considered for a live (living donor either related or unrelated to patient) donor kidney transplant.>

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  6. The patient is enrolled in another investigational study.>

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  7. The patient has co-morbid conditions that may limit their ability to comply with study and follow-up requirements.>

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  8. Study device is intended to be used temporarily.>

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  9. The patient has had >2 previous arteriovenous accesses in treatment arm.>

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  10. Patient is taking Aggrenox®.>

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  11. 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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  12. 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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  13. The patient has a known hypercoagulable or bleeding disorder or requires treatment with warfarin or heparin.>

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  14. Life expectancy is less than 12 months.>

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  15. The patient is pregnant.>

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  16. The patient is a poor compliance risk (i.e. history of IV or oral drug abuse).
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Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
138 participants (actual)

Study arms

  • Experimental
    GORE® ACUSEAL Vascular Graft

    Device: GORE® ACUSEAL Vascular Graft

Interventions

  • DeviceGORE® ACUSEAL Vascular Graft

    Surgical implantation of the GORE® ACUSEAL Vascular Graft for Hemodialysis per the Investigator's standard of practice.

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What researchers measure

Primary outcomes

  1. Cumulative Patency at 6 Months

    Percentage of subjects free from loss of access for hemodialysis at the study access site, assessed at 6 month.

    Time frame: 6 Months

  2. Freedom From Bleeding at 6 Months

    Percentage of subjects free from both major and minor bleeding events, assessed at 6-months

    Time frame: 6 Months

Secondary outcomes

  1. 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.

    Time frame: 6 Months

  2. 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.

    Time frame: 6 Months

  3. 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.

    Time frame: Time of access placement to first cannulation, assessed up to one week

  4. 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.

    Time frame: Initial study procedure to the third consecutive cannulation, assessed from day 3 thru day 123

07

Results

Posted Jul 2, 2013

Participant flow

Participant flow — Overall Study
MilestoneGORE® ACUSEAL Vascular Graft
Started138
Completed94
Not completed44
Withdrew: Death17
Withdrew: Abandonment of study graft27

Outcome measures

PrimaryCumulative Patency at 6 Months

Percentage of subjects free from loss of access for hemodialysis at the study access site, assessed at 6 month.

Time frame:
6 Months
Reported as:
Number · percentage of participants
Cumulative Patency at 6 Months
percentage of participantsGORE® ACUSEAL Vascular Graft
Cumulative Patency at 6 Months83.6 (76 to 89.5)
PrimaryFreedom From Bleeding at 6 Months

Percentage of subjects free from both major and minor bleeding events, assessed at 6-months

Time frame:
6 Months
Reported as:
Number · percentage of participants
Freedom From Bleeding at 6 Months
percentage of participantsGORE® ACUSEAL Vascular Graft
Freedom From Bleeding at 6 Months87.6 (80.1 to 93.1)
SecondaryPrimary 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.

Time frame:
6 Months
Reported as:
Number · percentage of participants
Primary Unassisted Patency at 6 Months
percentage of participantsGORE® ACUSEAL Vascular Graft
Primary Unassisted Patency at 6 Months45 (37.6 to 54.6)
SecondaryTime 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.

Time frame:
6 Months
Reported as:
Number · percentage of participants
Time to Event Analysis (Cumulative Patency)
percentage of participantsGORE® ACUSEAL Vascular Graft
Time to Event Analysis (Cumulative Patency)84.2 (76.8 to 89.4)
SecondaryTime 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.

Time frame:
Time of access placement to first cannulation, assessed up to one week
Reported as:
Number · percentage of grafts
Time to First Cannulation
percentage of graftsGORE® ACUSEAL Vascular Graft
Cannulated within 24 hours of procedure22.2
Cannulated within 48 hours of procedure35.6
Cannulated within 72 hours of procedure40.0
Cannulated within 1 week of procedure51.9
SecondaryTime 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.

Time frame:
Initial study procedure to the third consecutive cannulation, assessed from day 3 thru day 123
Reported as:
Median · days
Time to Potential Central Venous Catheter Removal
daysGORE® ACUSEAL Vascular Graft
Time to Potential Central Venous Catheter Removal15.5 (3 to 123)

Adverse events

Non-serious events are listed at a 5.0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
GORE® ACUSEAL Vascular Graft—74/138 (53.6%)0/138 (0%)
Most frequent serious events
Showing 10 of 132
Most frequent serious events
EventGORE® ACUSEAL Vascular Graft
Steal syndromeVascular disorders15/138
Arteriovenous graft site infectionInfections and infestations9/138
PneumoniaInfections and infestations7/138
AnemiaBlood and lymphatic system disorders6/138
HypotensionVascular disorders5/138
Congestive heart failureCardiac disorders4/138
Non STEMICardiac disorders4/138
SepsisInfections and infestations4/138
Mental status changesPsychiatric disorders4/138
Respiratory failureRespiratory, thoracic and mediastinal disorders4/138

Baseline characteristics

Age Continuous
Age Continuous(years)GORE® ACUSEAL Vascular Graft
Mean63 ± 13.8
Sex: Female, Male
Sex: Female, Male(Participants)GORE® ACUSEAL Vascular Graft
Female71
Male67
Region of Enrollment
Region of Enrollment(participants)GORE® ACUSEAL Vascular Graft
United States138
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Study locations

No study locations are listed for this record.

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References and documents

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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 26, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01173718
Lead sponsor
W.L.Gore & Associates
Responsible party
Sponsor
First posted
Aug 2, 2010
Start date
Jul 2010
Primary completion
Sep 2012
Completion
Feb 2013
Results posted
Jul 2, 2013
Last update
Jul 26, 2013

Study contacts

Marc Glickman, MD
principal investigator · Sentara Vascular Specialists

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.

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