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

Pervasis Therapeutics, Inc65 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Hemodialysis Access

Interventions

VascugelBIOLOGICAL

One time implant on the day of surgery

Placebo ComparatorBIOLOGICAL

One time implant on the day of surgery

Eligibility

Sex: ALLMin age: 18 YearsMax age: 89 Years

Medical Language ↔ Plain English

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.

Locations (1)

Brigham and Women's Hospital

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Safety of vascugel

Time frame: 6 months followed by 2.5 year extension

Data from ClinicalTrials.gov

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