Clinical trial NCT04783779: Evaluation of STARgraft-2 for Hemodialysis Access
Official title: Evaluation of STARgraft-2 for Hemodialysis Access
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End Stage Renal Disease
Keywords: Hemodialysis
Vascular Access
Arterio-Venous Grafts (AVG)
Lead sponsor: Healionics Corporation
Sponsor class: INDUSTRY
First posted: 2021-03-05
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

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:

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.


Eligibility 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. 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

Primary outcomes:
measure: Primary Unassisted Patency
timeFrame: 6 months post implantation.
Secondary outcomes:
measure: Primary Unassisted Patency
timeFrame: 1, 2, 4, 9 and 12 months post implantation
measure: Assisted Primary Patency
timeFrame: 1, 2, 4, 6, 9 and 12 months post implantation
measure: Secondary Patency (Cumulative Patency)
timeFrame: 1, 2, 4, 6, 9 and 12 months post implantation
measure: Graft Related Infections
timeFrame: 1, 2, 4, 6, 9 and 12 months post implantation
measure: Safety Outcomes
timeFrame: 1, 2, 4, 6, 9 and 12 months post implantation
Other outcomes:
measure: Blood Flow Rates in Grafts
timeFrame: 2 weeks and 1, 2, 4, 6, 9, 12 months post implantation.
measure: Peak Systolic Velocity (PSV) Ratio
timeFrame: 2 weeks and 1, 2, 4, 6, 9, 12 months post implantation
Locations:
city: Asunción
country: Paraguay
facility: Italian Hospital
Study officials:
affiliation: Italian Hospital Asuncion Paraguay
name: Adrian Ebner, MD
role: PRINCIPAL_INVESTIGATOR
References: