Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

COMPLETED

Evaluation of the GORE® ACUSEAL Vascular Graft for Hemodialysis Access

Lead Sponsor:

W.L.Gore & Associates

Conditions:

End Stage Renal Disease

Eligibility:

All Genders

18+ years

Phase:

PHASE2

PHASE3

Brief 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...

Eligibility Criteria

Inclusion

  • \>
  • 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. \>
  • \>\>
  • The patient is 18 years of age or older. \>
  • \>\>
  • The patient has a reasonable expectation of remaining on hemodialysis for 12 months. \>
  • \>\>
  • 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. \>
  • \>\>
  • \>
  • \>\>
  • \>
  • \>\>

Exclusion

  • \>
  • \>\>
  • <!-- -->
  • The patient has a documented and unsuccessfully treated ipsilateral central venous stenosis via imaging technique.\>
  • \>\>
  • The patient currently has a known or suspected systemic infection.\>
  • \>\>
  • The patient has a known hypercoagulable or bleeding disorder or requires treatment with warfarin or heparin.\>
  • \>\>
  • The patient has had a previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or has known sensitivity to heparin. \>
  • \>\>
  • The patient is being considered for a live (living donor either related or unrelated to patient) donor kidney transplant.\>
  • \>\>
  • The patient is enrolled in another investigational study.\>
  • \>\>
  • The patient has co-morbid conditions that may limit their ability to comply with study and follow-up requirements.\>
  • \>\>
  • Study device is intended to be used temporarily.\>
  • \>\>
  • The patient has had \>2 previous arteriovenous accesses in treatment arm.\>
  • \>\>
  • Patient is taking Aggrenox®.\>
  • \>\>
  • The patient is in need of, or is scheduled for a different vascular surgical procedure within 30 days of the study procedure.\>
  • \>\>
  • The patient is currently taking maintenance immunosuppressant medication such as rapamycin, mycophenolate or mycophenolic acid, prednisone(\>10 mg), cyclosporine, tacrolimus or cyclophosphamide.\>
  • \>\>
  • The patient has a known hypercoagulable or bleeding disorder or requires treatment with warfarin or heparin.\>
  • \>\>
  • Life expectancy is less than 12 months.\>
  • \>\>
  • The patient is pregnant.\>
  • \>\>
  • The patient is a poor compliance risk (i.e. history of IV or oral drug abuse).

Key Trial Info

Start Date :

July 1 2010

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

February 1 2013

Estimated Enrollment :

138 Patients enrolled

Trial Details

Trial ID

NCT01173718

Start Date

July 1 2010

End Date

February 1 2013

Last Update

July 26 2013

Active Locations (0)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 0 (0 locations)

No Results Found

We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.