Evaluation of STARgraft AV for Hemodialysis Access

NCT ID: NCT03916731

Last Updated: 2024-10-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-02
• Study Completion Date: 2021-05-11

Brief Summary

This study is a First-in-Human, single site, prospective, randomized, controlled evaluation of the safety and effectiveness of the Healionics STARgraft AV hemodialysis access graft. The STARgraft has been demonstrated in preclinical studies to have improved resistance to the common failure mode of venous anastomosis stenosis.

Performance of the STARgraft AV will be compared against 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. Demonstrate improved primary patency of the investigational STARgraft AV compared to the ePTFE controls over a period of 6 months, with extended results to 1 year.

2. Verify safety of the STARgraft AV multilayer construction in extended vascular access use.

It is intended to enroll 25 subjects each for the investigational devices and the controls respectively (50 total) with randomized device allocation at subject presentation for implant surgery.

Conditions

End Stage Renal Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

STARgraft AV

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

Group Type: EXPERIMENTAL

STARgraft AV

Intervention Type: DEVICE

Implant of STARgraft AV 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.

Control (ePTFE)

Participants will be implanted in the same upper arm location with standard 6mm diameter ePTFE dialysis access grafts. All other aspects of this study arm are identical to the Experimental one.

Group Type: ACTIVE_COMPARATOR

ePTFE AV graft (control)

Intervention Type: DEVICE

Implant of standard ePTFE AV shunt as a control 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.

Interventions

STARgraft AV

Implant of STARgraft AV 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

ePTFE AV graft (control)

Implant of standard ePTFE AV shunt as a control 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. Systolic blood pressure equal to or greater than 120 mmHg.

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

Exclusion Criteria

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

2. Pregnancy.

3. Clinical 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.

• 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 00355

Identifier Type: -

Identifier Source: org_study_id