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Evaluation of STARgraft-2 for Hemodialysis Access

Primary Purpose

End Stage Renal Disease

Status

Active

Phase

Not Applicable

Locations

Paraguay

Study Type

Interventional

Intervention

Implant of STARgraft-2 shunt in the upper arm and subsequent use for hemodialysis access

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 Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

STARgraft-2

Arm Description

Participants will be implanted with 6mm diameter STARgraft-2 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.

Graft Related Infections

Frequency and severity of infections related to graft placement and use for dialysis access.

Safety Outcomes

Frequency and Severity of Adverse Events resulting from graft implantation and use for hemodialysis access.

Full Information

NCT ID

NCT04783779

First Posted

March 2, 2021

Last Updated

September 20, 2023

Sponsor

Healionics Corporation

1. Study Identification

Unique Protocol Identification Number

NCT04783779

Brief Title

Evaluation of STARgraft-2 for Hemodialysis Access

Official Title

Evaluation of STARgraft-2 for Hemodialysis Access

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

February 16, 2021 (Actual)

Primary Completion Date

June 1, 2022 (Actual)

Study Completion Date

September 2023 (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

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

5. Study Description

Brief Summary

This study is a single site, prospective, single arm evaluation of the safety and effectiveness of the Healionics STARgraft-2 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 a prior First in Human (FIH) study (NCT03916731) with the STARgraft AV investigational device. That 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-2 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. Verify safety of the STARgraft-2 multilayer construction in extended dialysis vascular access use. It is intended to enroll 25 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

Model Description

All participants are implanted with the investigational grafts at a single site under consistent conditions. Study follow up examinations are performed at the same site. Routine dialysis procedures over the study period are performed at the participants established clinic.

Masking

None (Open Label)

Allocation

N/A

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

STARgraft-2

Arm Type

Experimental

Arm Description

Participants will be implanted with 6mm diameter STARgraft-2 grafts as an upper arm Brachial Artery to Axillary Vein shunt for hemodialysis access.

Intervention Type

Device

Intervention Name(s)

Implant of STARgraft-2 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

Graft Related Infections

Description

Frequency and severity of infections related to graft placement and use for dialysis access.

Time Frame

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

Other Pre-specified Outcome Measures:

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, 12 months post implantation.

Title

Peak Systolic Velocity (PSV) Ratio

Description

Ultrasound measurement of PSV (The ratio of flow velocity at the venous anastomosis to that at a point 2cm upstream in the graft)

Time Frame

2 weeks and 1, 2, 4, 6, 9, 12 months post implantation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

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

12. IPD Sharing Statement

Plan to Share IPD

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Evaluation of STARgraft-2 for Hemodialysis Access

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