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Comparison of the Human Acellular Vessel (HAV) With ePTFE Grafts as Conduits for Hemodialysis

NCT02644941 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 355

Last updated 2025-03-30

Study results available
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Summary

The main purpose of this study is to compare the Human Acellular Vessel (HAV) with ePTFE grafts when used for hemodialysis access.

Conditions

Interventions

BIOLOGICAL

Human Acellular Vessel (HAV)

HAV-tissue-engineered vascular conduit (6mm diameter)

DEVICE

ePTFE graft

One of two commercially available comparators (Bard Impra® and Gore PROPATEN®)

Sponsors & Collaborators

  • CTI Clinical Trial and Consulting Services

    collaborator OTHER

  • California Institute for Regenerative Medicine (CIRM)

    collaborator OTHER

  • Humacyte, Inc.

    lead INDUSTRY

Principal Investigators

  • Shamik Parikh, MD · Humacyte, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-24
Primary Completion
2019-05-31
Completion
2023-09-30

Countries

  • United States
  • Germany
  • Israel
  • Poland
  • Portugal
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02644941 on ClinicalTrials.gov