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Evaluation of STARgraft AV for Hemodialysis Access

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ClinicalTrials.gov Identifier: NCT03916731
Recruitment Status : Recruiting
First Posted : April 16, 2019
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Healionics Corporation

Tracking Information
First Submitted Date  ICMJE April 8, 2019
First Posted Date  ICMJE April 16, 2019
Last Update Posted Date April 16, 2019
Actual Study Start Date  ICMJE April 2, 2019
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 12, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 12, 2019)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: April 12, 2019)
  • Blood flow rates in grafts. [ Time Frame: 2 weeks and 1, 2, 4, 6, 9, 12 months post implantation. ]
    Ultrasound measurements of flow rates (ml/minute) to detect patency trends with time after implantation
  • Peak Systolic Velocity (PSV) Ratio [ Time Frame: 2 weeks and 1, 2, 4, 6, 9, 12 months post implantation ]
    Ultrasound measurement of PSV (The ratio of flow velocity at the venous anastomosis to that at a point 2cm upstream in the graft)
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Evaluation of STARgraft AV for Hemodialysis Access
Official Title  ICMJE First in Human Evaluation of STARgraft AV for Hemodialysis Access in Comparison to ePTFE Vascular Grafts
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Equal numbers of Participants are randomly assigned investigational or control grafts for implant. Study follow up examinations and routine dialysis procedures over the study period are identical for both groups.
Masking: Double (Participant, Care Provider)
Masking Description:
Randomized Assignment of Investigational and Control devices by Sponsor. Participants and Dialysis Clinics providing routine maintenance hemodialysis care are masked.
Primary Purpose: Treatment
Condition  ICMJE End Stage Renal Disease
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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.
    Intervention: Device: Implant of STARgraft AV shunt in the upper arm and subsequent use 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.
    Intervention: Device: Implant of standard ePTFE AV graft in the upper arm and subsequent use for hemodialysis access
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 12, 2019)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2020
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Andrew J Marshall, Ph.D 1 206 432 9060 ext 303 andrewm@healionics.com
Listed Location Countries  ICMJE Paraguay
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03916731
Other Study ID Numbers  ICMJE CIP 00355
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Healionics Corporation
Study Sponsor  ICMJE Healionics Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Adrian Ebner, MD Italian Hospital Asuncion Paraguay
PRS Account Healionics Corporation
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP