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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

240

Participants

Timeline

Start Date

September 29, 2017

Primary Completion Date

April 22, 2024

Study Completion Date

September 30, 2025

Conditions
Renal FailureEnd Stage Renal DiseaseHemodialysisVascular Access
Interventions
BIOLOGICAL

Human Acellular Vessel (HAV)

Surgical implantation of the HAV and subsequent use of the implanted vascular conduit for hemodialysis vascular access.

PROCEDURE

Arteriovenous fistula (AVF)

Surgical creation of an autologous arteriovenous fistula and subsequent use of the implanted vascular conduit for hemodialysis vascular access.

OTHER

Hemodialysis

Procedure that filters a person's blood when their kidneys are no longer functioning properly

Trial Locations (31)

15213

VA Pittsburgh, Pittsburgh

28207

Surgical Specialists of Charlotte, Charlotte

29118

The Regional Medical Center, Orangeburg

30303

Grady Memorial Hospital, Atlanta

32503

Coastal Vascular & Interventional, PLLC, Pensacola

33021

Memorial Healthcare System, Pembroke Pines

33606

Tampa General Hospital, Tampa

37920

University of Tennessee Knoxville, Knoxville

40504

United Surgical Associates, Lexington

62526

Decatur Memorial Hospital, Decatur

79416

South Plains Surgery Center, Lubbock

80204

Denver Health Medical Center, Denver

85012

Arizona Kidney Disease and Hypertension Center (AKDHC), Phoenix

85724

University of Arizona, Tucson

90033

University of Southern California, Los Angeles

90822

VA Long Beach Healthcare System, Long Beach

91105

Huntington Hospital, Pasadena

91342

Olive View- UCLA Medical Center, Sylmar

92103

University of California San Diego, Jacobs Medical Center, La Jolla

92123

Balboa Nephrology, San Diego

92161

University of CA, San Diego - LaJolla VA Hospital, La Jolla

92653

Alliance Research, Laguna Hills

92868

University of California, Irvine, Irvine

94401

Mills Peninsula Hospital, San Mateo

95817

UC Davis, Sacramento

97015

Kaiser Permanente Sunnsyide, Portland

06820

The Vascular Experts, Darien

02115

Brigham and Women's Hospital, Boston

01089

Kidney Care & Transplant Services of New England, West Springfield

07103

Rutgers University, Newark

07901

Overlook Medical Center, Summit

All Listed Sponsors
collaborator

CTI Clinical Trial and Consulting Services

OTHER

collaborator

California Institute for Regenerative Medicine (CIRM)

OTHER

lead

Humacyte, Inc.

INDUSTRY