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

PHASE3CompletedINTERVENTIONAL
Enrollment

355

Participants

Timeline

Start Date

May 24, 2016

Primary Completion Date

May 31, 2019

Study Completion Date

September 30, 2023

Conditions
Renal FailureEnd Stage Renal DiseaseHemodialysisVascular Access
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®)

Trial Locations (38)

21201

University of Maryland Medical Center, Baltimore

27705

Duke University Hospital, Durham

29118

Medical University of South Carolina (MUSC), Orangeburg

33606

University of South Florida, Tampa

38100

Hillel Jaffe Medical Center, Hadera

38930

Greenwood Leflore Hospital, Greenwood

48507

Michigan Cardiovascular Institute, Flint

52621

The Chaim Sheba Medical Center, Ramat Gan

53706

University of Wisconsin, Madison

60590

Universitätsklinikum Frankfurt Klinik für Gefäß- und Endovascular-Chirurgie, Frankfurt am Main

60803

Southwest Vascular Access Center, Alsip

63110

Washington University School of Medicine, St Louis

70300

Yitzhak Shamir Medical Center - Assaf Harofeh, Tzrifin

75226

Baylor Scott and White Research Institute, Dallas

85012

Arizona Kidney Disease and Hypertension Center (AKDHC), Phoenix

85745

Carondelet St. Mary's Hospital, Tucson

90822

VA Long Beach Healthcare System, Long Beach

91054

Universitätsklinikmn Erlangen, Gefäßchirurgie - Chirurgisches Zentrum, Erlangen

92123

Balboa Nephrology, San Diego

92868

University of California Irvine (UCI) Medical Center, Irvine

93710

Ladenheim Dialysis Access Center, Fresno

93720

General Surgery and Vascular Access, Fresno

95655

VA Sacramento Medical Center, Mather

97201

Kaiser Permanente, Portland

3109601

Rambam Health Care Campus, Haifa

9103102

Sharee Zedek Medical Center, Jerusalem

02115

Brigham and Women's Hospital, Boston

07103

Rutgers-New Jersey Medical School, Newark

07090

The Cardiovascular Care Group, Westfield

61-848

Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego, Poznan

02-097

Samodzielny Publiczyn Centralny Szpital Klinziczny w Warszawie - Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego, Warsaw

51-124

Wojewódzki Szpital Specjalistyczny we Wrocławiu, Wroclaw

4050-190

Grupo de Estudos Vasculares, Porto

LE5 4PW

Leicester General Hospital, Leicester

SE1 9RT

Guy´s Hospital, Kings´College London, London

B15 2TH

Queen Elizabeth Hospital Birmingham, Birmingham

G51 4TF

Queen Elizabeth University Hospital Glasgow, Glasgow

LS1 3EX

Leeds General Infirmary, Leeds

All Listed Sponsors
collaborator

CTI Clinical Trial and Consulting Services

OTHER

collaborator

California Institute for Regenerative Medicine (CIRM)

OTHER

lead

Humacyte, Inc.

INDUSTRY