Evaluation of STARgraft-2 for Hemodialysis Access

End Stage Renal Disease Clinical Trial

Official title:

Evaluation of STARgraft-2 for Hemodialysis Access

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04783779
• Other study ID #: CIP 00480 A
• Status: Completed
• Phase: N/A
• Start date: February 16, 2021
• Est. completion date: October 31, 2023

Study information

• Verified date: February 2024
• Source: Healionics Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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: 1. 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. 2. Verify safety of the STARgraft-2 multilayer construction in extended dialysis vascular access use. It is intended to enroll 25 subjects in this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 31, 2023
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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. Acceptable cardiac risk level (Cardiac Output = 3.5 L/min, Pulmonary Artery Pressure = 50 mmHg, Ejection Fraction = 40%)

10. Systolic blood pressure equal to or greater than 120 mmHg.

11. Absence of central venous stenosis downstream from implant site confirmed with ultrasound and/or venogram.

Exclusion Criteria:

1. Unable or unlikely to comply with trial protocol and/or follow-up.

2. Pregnancy.

3. Clinically 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.

15. Confirmed or suspected COVID-19 infection within 8 weeks prior to graft implant, or ongoing COVID-19 symptoms

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure, Chronic

Intervention

Device:
• Implant of STARgraft-2 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.

Locations

Country	Name	City	State
Paraguay	Italian Hospital	Asunción

Sponsors (1)

Lead Sponsor	Collaborator
Healionics Corporation

Country where clinical trial is conducted

Paraguay, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Blood Flow Rates in Grafts	Ultrasound measurements of flow rates (ml/minute) to detect patency trends with time after implantation	2 weeks and 1, 2, 4, 6, 9, 12 months post implantation.
Other	Peak Systolic Velocity (PSV) Ratio	Ultrasound measurement of PSV (The ratio of flow velocity at the venous anastomosis to that at a point 2cm upstream in the graft)	2 weeks and 1, 2, 4, 6, 9, 12 months post implantation
Primary	Primary Unassisted Patency	Percentage of subjects without an occurrence of either an access thrombosis or an access procedure performed to maintain patency.	6 months post implantation.
Secondary	Primary Unassisted Patency	Percentage of subjects without an occurrence of either an access thrombosis or an access procedure performed to maintain patency.	1, 2, 4, 9 and 12 months post implantation
Secondary	Assisted Primary Patency	Percentage of subjects retaining patency after one or more interventions so long as patency was not lost at any point.	1, 2, 4, 6, 9 and 12 months post implantation
Secondary	Secondary Patency (Cumulative Patency)	Percentage of subjects without loss of access at the original implant site.	1, 2, 4, 6, 9 and 12 months post implantation
Secondary	Graft Related Infections	Frequency and severity of infections related to graft placement and use for dialysis access.	1, 2, 4, 6, 9 and 12 months post implantation
Secondary	Safety Outcomes	Frequency and Severity of Adverse Events resulting from graft implantation and use for hemodialysis access.	1, 2, 4, 6, 9 and 12 months post implantation