Phase 3 N=138 Treatment

Evaluation of the GORE® ACUSEAL Vascular Graft for Hemodialysis Access

End Stage Renal Disease

Bottom Line

View on ClinicalTrials.gov: NCT01173718 ↗

Enrolled (actual)

138

Serious AEs

53.6%

Results posted

Jul 2013

Primary outcome: Primary: Cumulative Patency at 6 Months — 83.6 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: GORE® ACUSEAL Vascular Graft (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: W.L.Gore & Associates
Primary completion: Sep 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Cumulative Patency at 6 Months	83.6	—
PRIMARY Freedom From Bleeding at 6 Months	87.6	—
SECONDARY Primary Unassisted Patency at 6 Months	45	—
SECONDARY Time to Event Analysis (Cumulative Patency)	84.2	—
SECONDARY Time to First Cannulation	22.2; 35.6; 40.0; 51.9	—
SECONDARY Time to Potential Central Venous Catheter Removal	15.5	—

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). > >> > >> 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.

Eligibility Criteria

Inclusion Criteria:>

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 Criteria:>

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).

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01173718). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.