Post Market Study for VasQ, an External Support Implant for Arteriovenous Fistula

Part of paid clinical trials in Long Beach, California.

Sponsor
Laminate Medical Technologies
Study ID
NCT06516653
Status
Recruiting
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Conditions

  • End Stage Renal Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • VasQ — DEVICE
    External support implant for the arteriovenous fistula
  • Arteriovenous fistula creation for dialysis vascular access — PROCEDURE
    End to side fistula creation in the arm for dialysis vascular access

Study Details

VasQ is an external support implant for arteriovenous fistulas created for dialysis access. This is a postmarket surveillance, prospective, multi-center, randomized, controlled, open label trial enrolling 300 patients randomized into two study arms: * Treatment arm: End to side fistula supported with VasQ * Control: Standard of care end to side fistula

Key Dates

Start date
Jan 13, 2025
Status verified
Oct 2025
Primary completion
Aug 31, 2027
Completion
May 31, 2028

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: End to side fistula supported with VasQ
    Patients receiving an end to side arteriovenous fistula, supported by VasQ, for fistula access
  • Active Comparator: Standard of care end to side fistula
    Patients receiving an end to side arteriovenous fistula, for fistula access

Primary Outcome Measure

Fistula functional success [ Time Frame: 6 months ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Fresenius Vascular Care Long BeachLong BeachCalifornia90706
Deann Helton
[email protected]
562-888-8961
Anthony Becker, MD (PRINCIPAL_INVESTIGATOR)
Sarasota Memorial HospitalSarasotaFlorida34239
Kaitlyn Meek, RN
[email protected]
941-917-7109
Jason Wagner, MD (PRINCIPAL_INVESTIGATOR)
Brigham and Women's HospitalBostonMassachusetts02115
Danielle Montano
[email protected]
617-525-8555
Navya Kotturu
[email protected]
617-525-8555
Mohamad Hussain, MD (PRINCIPAL_INVESTIGATOR)
Greenwood Leflore HospitalGreenwoodMississippi38930
Kimberly McMillian
[email protected]
662-453-4641
John F Lucas, MD (PRINCIPAL_INVESTIGATOR)
Azura Surgery Center Las VegasLas VegasNevada99128
Taylor Ferraro
[email protected]
702-341-8031
Sabret Cafasso
[email protected]
702-341-8031
Peilin Wei, MD (PRINCIPAL_INVESTIGATOR)
Fresenius Vascular Care ColumbiaColumbiaSouth Carolina29203
Alicia Phillips-Pough
[email protected]
803-252-3373
Tami Hardwick
[email protected]
803-252-3373
Dion Franga, MD (PRINCIPAL_INVESTIGATOR)
Fairlawn Surgery CenterRoanokeVirginia24014
Aleisha Umber, RN
[email protected]
540-904-6170
Ryan Evans, MD (PRINCIPAL_INVESTIGATOR)

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Fresenius Vascular Care Long Beach· Long Beach, CASarasota Memorial Hospital· Sarasota, FLBrigham and Women's Hospital· Boston, MAGreenwood Leflore Hospital· Greenwood, MSAzura Surgery Center Las Vegas· Las Vegas, NVFresenius Vascular Care Columbia· Columbia, SC

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