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Evaluation of the GORE® ACUSEAL Vascular Graft for Hemodialysis Access (ACUSEAL)

Primary Purpose

End Stage Renal Disease

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

GORE® ACUSEAL Vascular Graft

About this trial

This is an interventional treatment trial for End Stage Renal Disease focused on measuring Hemodialysis, Vascular Graft

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

GORE® ACUSEAL Vascular Graft

Arm Description

Outcomes

Primary Outcome Measures

Cumulative Patency at 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

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

Secondary Outcome Measures

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 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 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 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.

Full Information

NCT ID

NCT01173718

First Posted

July 29, 2010

Last Updated

July 19, 2013

Sponsor

W.L.Gore & Associates

1. Study Identification

Unique Protocol Identification Number

NCT01173718

Brief Title

Evaluation of the GORE® ACUSEAL Vascular Graft for Hemodialysis Access

Acronym

ACUSEAL

Official Title

Evaluation of the GORE® ACUSEAL Vascular Graft for Hemodialysis Access (ACUSEAL, AVG 08-06)

Study Type

Interventional

2. Study Status

Record Verification Date

July 2013

Overall Recruitment Status

Completed

Study Start Date

July 2010 (undefined)

Primary Completion Date

September 2012 (Actual)

Study Completion Date

February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

W.L.Gore & Associates

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

End Stage Renal Disease

Keywords

Hemodialysis, Vascular Graft

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

138 (Actual)

8. Arms, Groups, and Interventions

Arm Title

GORE® ACUSEAL Vascular Graft

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

GORE® ACUSEAL Vascular Graft

Intervention Description

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

Primary Outcome Measure Information:

Title

Cumulative Patency at 6 Months

Description

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

Time Frame

6 Months

Title

Freedom From Bleeding at 6 Months

Description

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

Time Frame

6 Months

Secondary Outcome Measure Information:

Title

Primary Unassisted Patency at 6 Months

Description

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

Title

Time to Event Analysis (Cumulative Patency)

Description

Time Frame

6 Months

Title

Time to First Cannulation

Description

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

Title

Time to Potential Central Venous Catheter Removal

Description

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marc Glickman, MD

Organizational Affiliation

Sentara Vascular Specialists

Official's Role

Principal Investigator

12. IPD Sharing Statement

Citations:

PubMed Identifier

25953016

Citation

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.

Results Reference

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Evaluation of the GORE® ACUSEAL Vascular Graft for Hemodialysis Access

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