A Study to Evaluate the Safety and Effectiveness of the InnAVasc Arteriovenous Graft for Hemodialysis Access
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
Summary
- Conditions
- Chronic Renal Disease
- End Stage Renal Disease (ESRD)
- Kidney Failure
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: A prospective, multi-center, single-arm studyMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 90 years
- Gender
- Both males and females
Description
The InnAVasc AVG is intended for use in ESRD hemodialysis patients who require HD and whose next most appropriate access is an AVG, also including those who may require an immediate cannulation AVG. Patients with ESRD who require hemodialysis and are suitable for an AVG for hemodialysis access will ...
The InnAVasc AVG is intended for use in ESRD hemodialysis patients who require HD and whose next most appropriate access is an AVG, also including those who may require an immediate cannulation AVG. Patients with ESRD who require hemodialysis and are suitable for an AVG for hemodialysis access will be eligible for inclusion in the study. Subjects will be implanted with an InnAVasc AVG in the forearm or upper arm using standard vascular surgical techniques. The graft will be placed in a "straight" (soft "C") configuration in the upper arm, or looped configuration in the forearm (forearm loop) or upper arm (axillary loop). Placing the graft across the elbow will be prohibited. Subjects must be able to be on antiplatelet therapy per the discretion of their physician (i.e., aspirin, clopidogrel, etc.).
Tracking Information
- NCT #
- NCT04671771
- Collaborators
- Not Provided
- Investigators
- Study Director: Shawn Gage, PA-C InnAVasc Medical
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