Evaluation of the GORE® ACUSEAL Vascular Graft for Hemodialysis Access

NCT01173718 | Completed Phase 2 Results DMC

• 1 other identifier: AVG 08-06
• Study Type: interventional
• Target: 138
• Locations: 0 countries
• Sites: N/A

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.

Conditions

End Stage Renal Disease

Keywords

Hemodialysis; Vascular Graft

Outcome Measures

Primary Outcomes (2)

• Cumulative Patency at 6 Months

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

  6 Months

• Freedom From Bleeding at 6 Months

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

  6 Months

Secondary Outcomes (4)

• Primary Unassisted Patency at 6 Months

  6 Months

• Time to Event Analysis (Cumulative Patency)

  6 Months

• Time to First Cannulation

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

• Time to Potential Central Venous Catheter Removal

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

Study Arms (1)

GORE® ACUSEAL Vascular Graft

EXPERIMENTAL

Device: GORE® ACUSEAL Vascular Graft

Interventions

GORE® ACUSEAL Vascular Graft DEVICE

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

GORE® ACUSEAL Vascular Graft

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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• The patient has a documented and unsuccessfully treated ipsilateral central venous stenosis via imaging technique.\>
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• The patient currently has a known or suspected systemic infection.\>
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• The patient has a known hypercoagulable or bleeding disorder or requires treatment with warfarin or heparin.\>
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• 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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• The patient is being considered for a live (living donor either related or unrelated to patient) donor kidney transplant.\>
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• The patient is enrolled in another investigational study.\>
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• The patient has co-morbid conditions that may limit their ability to comply with study and follow-up requirements.\>

Sponsors & Collaborators

• W.L.Gore & Associates: lead

Related Publications (1)

• 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.

  PMID: 25953016 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Debby Pfile, Clinical Research Associate
• Organization: W. L. Gore & Associates

dpfile@wlgore.com

623-234-5226

Study Officials

• Marc Glickman, MD

  Sentara Vascular Specialists

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2010
• First Posted: August 2, 2010
• Study Start: July 1, 2010
• Primary Completion: September 1, 2012
• Study Completion: February 1, 2013
• Last Updated: July 26, 2013
• Results First Posted: July 2, 2013

Record last verified: 2013-07