Evaluation of STARgraft AV for Hemodialysis Access

Overview

This study is a First-in-Human, single site, prospective, randomized, controlled evaluation of the safety and effectiveness of the Healionics STARgraft AV hemodialysis access graft. The STARgraft has been demonstrated in preclinical studies to have improved resistance to the common failure mode of venous anastomosis stenosis. Performance of the STARgraft AV will be compared against control implants of commercially available standard ePTFE grafts approved for the same use. The study is enrolling patients with End Stage Renal Disease (ESRD) requiring hemodialysis via a prosthetic vascular graft. The study proposes to: 1. Demonstrate improved primary patency of the investigational STARgraft AV compared to the ePTFE controls over a period of 6 months, with extended results to 1 year. 2. Verify safety of the STARgraft AV multilayer construction in extended vascular access use. It is intended to enroll 25 subjects each for the investigational devices and the controls respectively (50 total) with randomized device allocation at subject presentation for implant surgery.

Full Title of Study: “First in Human Evaluation of STARgraft AV for Hemodialysis Access in Comparison to ePTFE Vascular Grafts”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Care Provider)
  • Study Primary Completion Date: April 17, 2020

Interventions

  • Device: Implant of STARgraft AV shunt in the upper arm and subsequent use for hemodialysis access
    • After healing from the surgical procedure the graft will be routinely cannulated for hemodialysis sessions. Periodic evaluations of blood flow by ultrasound imaging will be made over the study period. Established standards of care will be followed as needed to maintain dialysis function
  • Device: Implant of standard ePTFE AV graft in the upper arm and subsequent use for hemodialysis access
    • Same as for STARgraft AV but with standard grafts to provide controls

Arms, Groups and Cohorts

  • Experimental: STARgraft AV
    • Participants will be implanted with 6mm diameter STARgraft AV grafts as an upper arm Brachial Artery to Axillary Vein shunt for hemodialysis access.
  • Active Comparator: Control (ePTFE)
    • Participants will be implanted in the same upper arm location with standard 6mm diameter ePTFE dialysis access grafts. All other aspects of this study arm are identical to the Experimental one.

Clinical Trial Outcome Measures

Primary Measures

  • Primary Unassisted Patency
    • Time Frame: 6 months post implantation.
    • Percentage of subjects without an occurrence of either an access thrombosis or an access procedure performed to maintain patency.

Secondary Measures

  • Primary Unassisted Patency
    • Time Frame: 1, 2, 4, 9 and 12 months post implantation
    • Percentage of subjects without an occurrence of either an access thrombosis or an access procedure performed to maintain patency.
  • Assisted Primary Patency
    • Time Frame: 1, 2, 4, 6, 9 and 12 months post implantation
    • Percentage of subjects retaining patency after one or more interventions so long as patency was not lost at any point.
  • Secondary Patency (Cumulative Patency)
    • Time Frame: 1, 2, 4, 6, 9 and 12 months post implantation
    • Percentage of subjects without loss of access at the original implant site.
  • Graft Related Infections
    • Time Frame: 1, 2, 4, 6, 9 and 12 months post implantation
    • Frequency of infections related to graft placement and use for dialysis access.
  • Safety Outcomes
    • Time Frame: 1, 2, 4, 6, 9 and 12 months post implantation
    • Frequency and Severity of Adverse Events resulting from graft implantation and use for hemodialysis access.

Participating in This Clinical Trial

Inclusion Criteria

1. Male or female, > 18 years or age. 2. Patient has given informed consent to participate in the trial. 3. Stated willingness to comply with all study procedures and availability for the duration of the study. 4. Able to effectively communicate with study personnel. 5. Candidate for a new arterio-venous graft placed in the upper arm. 6. Life expectancy judged to be at least 2 years. 7. Axillary vein of greater than or equal to 7 mm in diameter. 8. Brachial artery of greater than or equal to 4 mm in diameter. 9. Systolic blood pressure equal to or greater than 120 mmHg. 10. Absence of central venous stenosis downstream from implant site confirmed with ultrasound and/or angiogram. Exclusion Criteria:

1. Unable or unlikely to comply with trial protocol and/or follow-up. 2. Pregnancy. 3. Clinical morbid obesity. 4. Anatomical limitations. 5. Immunodeficiency syndrome. 6. History of bacterial infection within 8 weeks prior to graft implantation. 7. History of hypercoagulation or bleeding disorders. 8. Elevated platelet count > 1 million per microliter of blood. 9. History of heparin-induced thrombocytopenia syndrome (HIT). 10. Medically confirmed stenosis of the veins downstream of the implant site. 11. Inadequate arterial flow or pressure proximal to the implant site. 12. Currently participating in another investigation drug or device study which may clinically interfere with any endpoints of this trial. 13. Fever greater than 38° C. 14. Prior allergic reaction to silicone.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Healionics Corporation
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Adrian Ebner, MD, Principal Investigator, Italian Hospital Asuncion Paraguay

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