Text Size

Evaluation of the GORE ACUSEAL Vascular Graft for Hemodialysis Access

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
W.L.Gore & Associates
ClinicalTrials.gov Identifier:
NCT01173718
First received: July 29, 2010
Last updated: February 4, 2013
Last verified: February 2013
History of Changes
  Purpose

This study will be a prospective, non-randomized, multi-center evaluation of the performance of the GORE ACUSEAL Vascular Graft. The ACUSEAL 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.


Condition Intervention Phase
Hemodialysis
 Device: GORE ACUSEAL Vascular Graft
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of the GORE ACUSEAL Vascular Graft for Hemodialysis Access (ACUSEAL, AVG 08-06)

Resource links provided by NLM:

MedlinePlus related topics: Dialysis
U.S. FDA Resources

Further study details as provided by W.L.Gore & Associates:

Primary Outcome Measures:
  • Cumulative Patency at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Percentage of Subjects free from loss of access for hemodialysis at the study access site, assessed at 6 month.


Secondary Outcome Measures:
  • Freedom from bleeding at 6 mos [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Percentage of subjects free from both major and minor bleeding events, assessed at 6-months


Enrollment: 138
Study Start Date: July 2010
Estimated Study Completion Date: April 2013
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GORE ACUSEAL Vascular Graft Device: GORE ACUSEAL Vascular Graft
Surgical implantation of the GORE ACUSEAL Graft for Hemodialysis per the Investigator's standard of practice.
Other Name: Vascular graft

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient requires the creation of a vascular access graft for hemodialysis secondary to a diagnosis of End-Stage Renal Disease.
  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.
  4. The patient is 18 years of age or older.
  5. The patient has a reasonable expectation of remaining on hemodialysis for 12 months.
  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.

Exclusion Criteria:

  1. The patient has a documented and unsuccessfully treated ipsilateral central venous stenosis via imaging technique.
  2. The patient currently has a known or suspected systemic infection.
  3. The patient has a known hypercoagulable or bleeding disorder or requires treatment with warfarin or heparin.
  4. The patient has had a previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or has known sensitivity to heparin.
  5. The patient is being considered for a live (living donor either related or unrelated to patient) donor kidney transplant.
  6. The patient is enrolled in another investigational study.
  7. The patient has co-morbid conditions that may limit their ability to comply with study and follow-up requirements.
  8. Study device is intended to be used temporarily.
  9. The patient hs had >2 previous arteriovenous accesses in treatment arm.
  10. Patient is taking Aggrenox.
  11. The patient is in need of, or is scheduled for a different vascular surgical procedure within 30 days of the study procedure.
  12. The patient is currently taking maintenance immunosuppressant medication such as rapamycin, mycophenolate or mycophenolic acid, prednison (>10 mg), cyclosporine, tacrolimus or cyclophosphamide.
  13. The patient has a known hypercoagulable or bleeding disorder or requires treatment with warfarin or heparin.
  14. Life expectancy is less than 12 months.
  15. The patient is pregnant.
  16. The patient is a poor compliance risk (i.e. history of IV or oral drug abuse).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01173718

Sponsors and Collaborators
W.L.Gore & Associates
Investigators
Principal Investigator: Marc Glickman, MD Sentara Vascular Specialists
  More Information

No publications provided

Responsible Party: W.L.Gore & Associates
ClinicalTrials.gov Identifier: NCT01173718     History of Changes
Other Study ID Numbers: AVG 08-06
Study First Received: July 29, 2010
Last Updated: February 4, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by W.L.Gore & Associates:
Hemodialysis
Vascular Graft
End Stage Renal Disease

ClinicalTrials.gov processed this record on June 19, 2013