Evaluation of STARgraft AV for Hemodialysis Access

• Sponsor: Healionics Corporation
• Information provided by (Responsible Party): Healionics Corporation

Study Description

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.

Condition or disease	Intervention/treatment	Phase
End Stage Renal Disease	Device: Implant of STARgraft AV shunt in the upper arm and subsequent use for hemodialysis access; Device: Implant of standard ePTFE AV graft in the upper arm and subsequent use for hemodialysis access	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 50 participants
• 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
• Official Title: First in Human Evaluation of STARgraft AV for Hemodialysis Access in Comparison to ePTFE Vascular Grafts
• Actual Study Start Date: April 2, 2019
• Estimated Primary Completion Date: November 2019
• Estimated Study Completion Date: September 2020

Arms and Interventions

Arm	Intervention/treatment
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.	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
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.	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

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

1. 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.
2. 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.
3. 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.
4. 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.
5. 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.

Other Outcome Measures:

1. 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
2. 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)

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Contacts

Contact: Andrew J Marshall, Ph.D; 1 206 432 9060 ext 303; andrewm@healionics.com

Locations

Paraguay

Italian Hospital; Recruiting

Asunción, Paraguay

Contact: Adrian Ebner, MD + 595 21 202 767 adrian_ebner@yahoo.com

Sponsors and Collaborators

Healionics Corporation

Investigators

• Principal Investigator: Adrian Ebner, MD; Italian Hospital Asuncion Paraguay

More Information

• Responsible Party: Healionics Corporation
• ClinicalTrials.gov Identifier: NCT03916731 History of Changes
• Other Study ID Numbers: CIP 00355
• First Posted: April 16, 2019
• Last Update Posted: April 16, 2019
• Last Verified: April 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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
• Pediatric Postmarket Surveillance of a Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Healionics Corporation:

Hemodialysis; Vascular Access; Arterio-Venous Grafts (AVG)

Additional relevant MeSH terms:

Kidney Failure, Chronic; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases