Post-market Surveillance Study of the BD® WavelinQ™ EndoAVF System

Part of paid clinical trials in La Jolla, California.

Sponsor
C. R. Bard
Study ID
NCT04634916
Status
Recruiting
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Conditions

  • Arteriovenous Fistula
  • End-stage Renal Disease
  • Kidney Disease, End-Stage

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • EndoAVF Creation — DEVICE
    Subjects will have an endoAVF created using the WavelinQ EndoAVF System

Study Details

A prospective, single-arm, multi-center post-market surveillance study of the BD® WavelinQ™ EndoAVF System for the Creation of Arteriovenous (AV) Fistula in Patients Requiring Dialysis.

Key Dates

Start date
Mar 26, 2021
Status verified
Mar 2026
Primary completion
Jun 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
280 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: EndoAVF

Primary Outcome Measure

Functional Cannulation Success [ Time Frame: 6-months post index procedure ]

Central Contacts

Locations (16)

FacilityCityStateZIPSite coordinators
California Institute of Renal ResearchLa JollaCalifornia92037
Karina Maldonado
[email protected]
San Francisco Vein & VascularSan FranciscoCalifornia94117
Patti O'Kelly
[email protected]
415-230-2421
Daniel Nathanson, MD (PRINCIPAL_INVESTIGATOR)
First Coast Cardiovascular Institute PaJacksonvilleFlorida32256
Yazan Khatib, MD (PRINCIPAL_INVESTIGATOR)
Radiology and Imaging SpecialistsLakelandFlorida33801
Vascular and Spine Institute IncMiamiFlorida33156-
Kidney Care and Transplant Services of NESpringfieldMassachusetts01089
Lynn Pratt, BSN
(413) 747-1817
Kidney Care & Transplant Services of New EnglandWest SpringfieldMassachusetts01089
Aleksandr Kurbanov, MD (PRINCIPAL_INVESTIGATOR)
UMass Chan School of MedicineWorcesterMassachusetts01655
Mollynda McArthur
[email protected]
774-443-0872
Dejah Judelson, MD (PRINCIPAL_INVESTIGATOR)
Albany Medical CenterAlbanyNew York12208
Stephanie Collins
[email protected]
Paul Kreienberg, MD (PRINCIPAL_INVESTIGATOR)
NC NephrologyRaleighNorth Carolina27609-
ProMedica Toledo HospitalToledoOhio43606
Mohamed Osman, MD (PRINCIPAL_INVESTIGATOR)
Butler Memorial HospitalButlerPennsylvania16001
Jenny Kopp, RN
[email protected]
1-833-808-2273
Brandon Repko, MD (PRINCIPAL_INVESTIGATOR)
Vascular Institute of ChattanoogaChattanoogaTennessee37421
Christopher Lesar, MD (PRINCIPAL_INVESTIGATOR)
Bluff City VascularMemphisTennessee38104
Terry Litchfield
[email protected]
(901) 726-1130
University of Texas Southwestern Medical CenterDallasTexas75390
Aria Nazeri, MD (PRINCIPAL_INVESTIGATOR)
Houston MethodistHoustonTexas77030
Ruth Medcalf
[email protected]

Find similar trials in La Jolla, CA

By research site
California Institute of Renal Research· La Jolla, CASan Francisco Vein & Vascular· San Francisco, CAFirst Coast Cardiovascular Institute Pa· Jacksonville, FLRadiology and Imaging Specialists· Lakeland, FLVascular and Spine Institute Inc· Miami, FLKidney Care and Transplant Services of NE· Springfield, MA

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