Comparison of the Human Acellular Vessel (HAV) With ePTFE Grafts as Conduits for Hemodialysis
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 350
Summary
- Conditions
- End Stage Renal Disease
- Hemodialysis
- Renal Failure
- Vascular Access
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
This is a Phase 3, prospective, multicenter, multinational, open-label, randomized, two-arm, comparative study. Subjects who sign informed consent would undergo study-specific screening assessments within 35 days from the day of informed consent. On the day of surgery (Day 0), subjects could still b...
This is a Phase 3, prospective, multicenter, multinational, open-label, randomized, two-arm, comparative study. Subjects who sign informed consent would undergo study-specific screening assessments within 35 days from the day of informed consent. On the day of surgery (Day 0), subjects could still be undergoing screening assessments, such as confirmation of inclusion/exclusion criteria, to determine their eligibility before they are randomized in the study. Eligible study subjects will be randomized to receive either a HAV or one of two commercially available ePTFE grafts and followed to 24 months post-implantation at routine study visits regardless of patency status. After 24 months, subjects with a patent study conduit will be followed (while the study conduit remains patent) for up to 5 years (60 months) post implantation at routine study visits.
Tracking Information
- NCT #
- NCT02644941
- Collaborators
- CTI Clinical Trial and Consulting Services
- California Institute for Regenerative Medicine (CIRM)
- Investigators
- Study Director: Kiernan DeAngelis, MD Humacyte, Inc.
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