Safety of Vascugel Treatment After Creation of Arteriovenous Access for Hemodialysis Use

Study Overview
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Brief Summary
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Vascugel™ is safe when placed at the anastomotic site at the time of surgery during creation of an AV graft or fistula for hemodialysis access.

Detailed Description
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Randomized, double-blind, parallel group, Phase I/II clinical trial of Vascugel™ treatment vs. Gelfoam® in patients undergoing creation of an arteriovenous graft or fistula for hemodialysis access. All patients will undergo preoperative duplex ultrasound imaging and/or angiography (whatever is the standard of care at the research site) of the vein and artery to evaluate the optimal site for vascular access placement in the upper extremity. Patients will be examined with Doppler ultrasound or standard of care immediately after surgery to verify patency of the AV graft or fistula. During the follow-up period, each patient will undergo a physical examination and imaging of the vascular access at specified intervals.

Official Title
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Safety of Vascugel Treatment After Creation of Arteriovenous Access for Hemodialysis Use

Conditions
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Hemodialysis Access

Intervention / Treatment
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* Biological: Vascugel
* Biological: Placebo Comparator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult male or female patients (ages of 18 to 89, inclusive) who are undergoing placement of an AV graft or fistula for hemodialysis access Exclusion Criteria: Patient is currently on an active transplant list for a kidney from a deceased donor OR is undergoing assessment and expects to be placed on the active transplant list within the next twenty-four weeks OR expects to receive a living donor kidney within twenty-four weeks. Patient is expecting another solid organ transplant or a bone marrow transplant. Patient has had more than one access surgery (defined as a new access, not a revision) in the target limb. Patient is currently on chronic, systemic immunosuppressant medication other than locally or topically applied steroids.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AVG1<br>Vascugel | Biological: Vascugel<br>* One time implant on the day of surgery<br>|
| Placebo Comparator: AVG2<br>Gelfoam | Biological: Placebo Comparator<br>* One time implant on the day of surgery<br>|
| Experimental: AVF3<br>Vascugel | Biological: Vascugel<br>* One time implant on the day of surgery<br>|
| Placebo Comparator: AVF4<br>Gelfoam | Biological: Placebo Comparator<br>* One time implant on the day of surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of vascugel |  | 6 months followed by 2.5 year extension | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemodialysis access, Arteriovenous graft, Arteriovenous fistula, End stage renal disease