Multi-Site STARgraft (10401) Trial

ConditionEnd Stage Renal Disease (ESRD)

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorHealionics Corporation

About this trial

This is a multi-site, single-blind with parallel group, randomized controlled trial of Healionics STARgraft (10401) vascular graft for hemodialysis access compared with a market-leading commercially available ePTFE vascular graft (Gore Propaten Vascular Graft).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

The patient requires the creation of vascular access for hemodialysis secondary to a diagnosis of End-Stage Renal Disease (ESRD) and intends to use the Vascular Graft device for arteriovenous (AV) access.

The patient is currently on hemodialysis or intended to begin hemodialysis within 60 days following placement of the device.

Adult patients, 18 years or older.

Patient has given informed consent to participate in the trial.

Disqualifiers

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

Pregnancy.

Previous history of peritoneal dialysis (PD) treatment within the last 2 months

Central venous catheter located on same side as intended implant location.

Trial design

Design model

Parallel

Treatments tested in this trial

STARgraft (10401)
Device
Device: STARgraft (10401) Surgical implantation of STARgraft (10401) for Hemodialysis in the upper forearm.
Gore Propaten
Device
Device: Gore Propaten Surgical implantation of Gore Propaten for Hemodialysis in the upper forearm.

Treatment groups

111 Participants

are divided into 2 treatment groups

Group A: STARgraft (10401)Experimental treatment 1 intervention

Group B: Gore PropatenActive comparator 1 intervention

Trial outcomes

Primary outcomes

Safety: Subjects with Major Adverse Event

Percent of subjects with major adverse event, defined as adverse events resulting from graft implantation or use for dialysis; and requiring surgical or endovascular intervention, or impacting or delaying graft use.

Time frame

6 months

Effectiveness: Primary Unassisted Patency

Measured as the percentage of patients retaining PUP at the timepoint. Loss of primary unassisted patency is defined as use of any intervention to maintain full function of the permanent access: angioplasty, surgery of any type (such as for an pseudoaneurysm), thrombectomy or thrombolysis, or creation of an entirely new access.

Time frame

6 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Healionics Corporation

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: