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Evaluation of STARgraft-3 for Hemodialysis

Primary Purpose

End Stage Renal Disease

Status
Recruiting
Phase
Not Applicable
Locations
Paraguay
Study Type
Interventional
Intervention
Implant of STARgraft-3 shunt in the upper arm and subsequent use for hemodialysis access
Sponsored by
Healionics Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End Stage Renal Disease focused on measuring Hemodialysis, Vascular Access, Arterio-Venous Grafts (AVG)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male or female, > 18 years or age. Patient has given informed consent to participate in the trial. Stated willingness to comply with all study procedures and availability for the duration of the study. Able to effectively communicate with study personnel. Candidate for a new arterio-venous graft placed in the upper arm. Life expectancy judged to be at least 2 years. Axillary vein of greater than or equal to 7 mm in diameter. Brachial artery of greater than or equal to 4 mm in diameter. Acceptable cardiac risk level (Cardiac Output ≥ 3.5 L/min, Pulmonary Artery Pressure ≤ 50 mmHg, Ejection Fraction ≥ 40%) Systolic blood pressure equal to or greater than 120 mmHg. Absence of central venous stenosis downstream from implant site confirmed with ultrasound and/or venogram. Exclusion Criteria: Unable or unlikely to comply with trial protocol and/or follow-up. Pregnancy. Clinically morbid obesity. Anatomical limitations. Immunodeficiency syndrome. History of bacterial infection within 8 weeks prior to graft implantation. History of hypercoagulation or bleeding disorders. Elevated platelet count > 1 million per microliter of blood. History of heparin-induced thrombocytopenia syndrome (HIT). Medically confirmed stenosis of the veins downstream of the implant site. Inadequate arterial flow or pressure proximal to the implant site. Currently participating in another investigation drug or device study which may clinically interfere with any endpoints of this trial. Fever greater than 38°C. Prior allergic reaction to silicone. Confirmed or suspected COVID-19 infection within 8 weeks prior to graft implant, or ongoing COVID-19 symptoms.

Sites / Locations

  • Italian HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

STARgraft-3

Arm Description

Participants will be implanted with 6mm diameter STARgraft-3 grafts as an upper arm Brachial Artery to Axillary Vein shunt for hemodialysis access.

Outcomes

Primary Outcome Measures

Primary Unassisted Patency
Percentage of subjects without an occurrence of either an access thrombosis or an access procedure performed to maintain patency.

Secondary Outcome Measures

Primary Unassisted Patency
Percentage of subjects without an occurrence of either an access thrombosis or an access procedure performed to maintain patency.
Assisted Primary Patency
Percentage of subjects retaining patency after one or more interventions so long as patency was not lost at any point.
Secondary Patency (Cumulative Patency)
Percentage of subjects without loss of access at the original implant site.
Frequency of Interventions
Frequency of interventions related to graft placement and use for dialysis access.
Blood Flow Rates in Grafts
Ultrasound measurements of flow rates (ml/minute) to detect patency trends with time after implantation.
Safety Outcomes
Frequency and severity of Adverse Events resulting from graft implantation and use for hemodialysis access.

Full Information

First Posted
February 6, 2023
Last Updated
February 6, 2023
Sponsor
Healionics Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT05729620
Brief Title
Evaluation of STARgraft-3 for Hemodialysis
Official Title
Evaluation of STARgraft-3 for Hemodialysis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 29, 2022 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Healionics Corporation

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is a single site, prospective, single arm evaluation of the safety and effectiveness of the Healionics STARgraft-3 hemodialysis access graft. STARgraft devices have been demonstrated in preclinical and other studies to have improved resistance to the common failure modes of venous anastomosis stenosis and infection. This study is an extension from prior studies with STARgraft AV (NCT03916731) and STARgraft-2 (NCT04783779) investigational devices. A previous study also included 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 evaluate the performance of the investigational STARgraft-3 compared to the ePTFE controls in the prior study and to published results, over a period of 6 months, with extended results to 1 year. Estimated enrollment is 15 subjects in this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease
Keywords
Hemodialysis, Vascular Access, Arterio-Venous Grafts (AVG)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
STARgraft-3
Arm Type
Experimental
Arm Description
Participants will be implanted with 6mm diameter STARgraft-3 grafts as an upper arm Brachial Artery to Axillary Vein shunt for hemodialysis access.
Intervention Type
Device
Intervention Name(s)
Implant of STARgraft-3 shunt in the upper arm and subsequent use for hemodialysis access
Intervention Description
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.
Primary Outcome Measure Information:
Title
Primary Unassisted Patency
Description
Percentage of subjects without an occurrence of either an access thrombosis or an access procedure performed to maintain patency.
Time Frame
6 months post implantation
Secondary Outcome Measure Information:
Title
Primary Unassisted Patency
Description
Percentage of subjects without an occurrence of either an access thrombosis or an access procedure performed to maintain patency.
Time Frame
1, 2, 4, 9 and 12 months post implantation
Title
Assisted Primary Patency
Description
Percentage of subjects retaining patency after one or more interventions so long as patency was not lost at any point.
Time Frame
1, 2, 4, 6, 9, and 12 months post implantation
Title
Secondary Patency (Cumulative Patency)
Description
Percentage of subjects without loss of access at the original implant site.
Time Frame
1, 2, 4, 6, 9, and 12 months post implantation
Title
Frequency of Interventions
Description
Frequency of interventions related to graft placement and use for dialysis access.
Time Frame
1, 2, 4, 6, 9 and 12 months post implantation
Title
Blood Flow Rates in Grafts
Description
Ultrasound measurements of flow rates (ml/minute) to detect patency trends with time after implantation.
Time Frame
2 weeks and 1, 2, 4, 6, 9, and 12 months post implantation
Title
Safety Outcomes
Description
Frequency and severity of Adverse Events resulting from graft implantation and use for hemodialysis access.
Time Frame
1, 2, 4, 6, 9, and 12 months post implantation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female, > 18 years or age. Patient has given informed consent to participate in the trial. Stated willingness to comply with all study procedures and availability for the duration of the study. Able to effectively communicate with study personnel. Candidate for a new arterio-venous graft placed in the upper arm. Life expectancy judged to be at least 2 years. Axillary vein of greater than or equal to 7 mm in diameter. Brachial artery of greater than or equal to 4 mm in diameter. Acceptable cardiac risk level (Cardiac Output ≥ 3.5 L/min, Pulmonary Artery Pressure ≤ 50 mmHg, Ejection Fraction ≥ 40%) Systolic blood pressure equal to or greater than 120 mmHg. Absence of central venous stenosis downstream from implant site confirmed with ultrasound and/or venogram. Exclusion Criteria: Unable or unlikely to comply with trial protocol and/or follow-up. Pregnancy. Clinically morbid obesity. Anatomical limitations. Immunodeficiency syndrome. History of bacterial infection within 8 weeks prior to graft implantation. History of hypercoagulation or bleeding disorders. Elevated platelet count > 1 million per microliter of blood. History of heparin-induced thrombocytopenia syndrome (HIT). Medically confirmed stenosis of the veins downstream of the implant site. Inadequate arterial flow or pressure proximal to the implant site. Currently participating in another investigation drug or device study which may clinically interfere with any endpoints of this trial. Fever greater than 38°C. Prior allergic reaction to silicone. Confirmed or suspected COVID-19 infection within 8 weeks prior to graft implant, or ongoing COVID-19 symptoms.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrew J Marshall, PhD
Phone
1 206 432 9060
Ext
303
Email
andrewm@healionics.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adrian Ebner, MD
Organizational Affiliation
Italian Hospital Asuncion Paraguay
Official's Role
Principal Investigator
Facility Information:
Facility Name
Italian Hospital
City
Asunción
Country
Paraguay
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adrian Ebner, MD
Phone
+ 595 21 202 767
Email
adrian_ebner@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Evaluation of STARgraft-3 for Hemodialysis

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