Evaluation of STARgraft-3 for Hemodialysis

NCT ID: NCT05729620

Last Updated: 2024-02-01

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-29
• Study Completion Date: 2024-07-31

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.

Conditions

End Stage Renal Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

STARgraft-3

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

Group Type: EXPERIMENTAL

Implant of STARgraft-3 shunt in the upper arm and subsequent use for hemodialysis access

Intervention Type: DEVICE

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.

Interventions

Implant of STARgraft-3 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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Healionics Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adrian Ebner, MD

Role: PRINCIPAL_INVESTIGATOR

Italian Hospital Asuncion Paraguay

Locations

Italian Hospital

Asunción, , Paraguay

Countries

Paraguay

Other Identifiers

CIP 00530

Identifier Type: -

Identifier Source: org_study_id