STARgraft (10401) Pilot
ConditionEnd Stage Kidney Disease (ESRD)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHealionics Corporation
About this trial
This study is a single site, prospective, single arm evaluation of the safety and effectiveness of the Healionics STARgraft (10401) hemodialysis access graft.
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 (10401) compared to the ePTFE controls in a prior study (NCT03916731) and to published results, over a period of 6 months. Additional data out to 36 months post-implantation may be captured.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients, 18 years or older.
Patient has given informed consent to participate in the trial.
Stated willingness to comply with all trial procedures and availability for the duration of the trial.
Able to effectively communicate with trial personnel.
Disqualifiers
Unable or unlikely to comply with trial protocol and/or follow-up.
Pregnancy.
Previous history of Peritoneal Dialysis treatment within the last 2 months
Central venous catheter located on same side as intended implant location.
Trial design
Design model
Single group
Treatments tested in this trial
STARgraft (10401)
DeviceParticipants will be implanted with 6mm diameter STARgraft (10401) grafts as an upper arm Brachial Artery to Axillary Vein shunt for hemodialysis access.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: STARgraft (10401)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Effectiveness - Primary unassisted patency
Primary unassisted patency, defined as the percentage of grafts retaining adequate flow for dialysis without requiring any surgical or endovascular procedure to maintain or re-establish its function.
Time frame
6 months2
Safety - Serious Device Related Adverse Events
Incidence of serious device-related adverse events.
Time frame
6 monthsSecondary outcomes
1
Primary unassisted patency
Primary unassisted patency, defined as the percentage of grafts retaining adequate flow for dialysis without requiring any surgical or endovascular procedure to maintain or re-establish its function.
Time frame
12, 18, 24 and 36 months2
Assisted primary patency
Measured as the percentage of patients retaining assisted primary patency at the timepoints. Assisted primary patency begins when an access requires surgical or endovascular interventions designed to maintain the functionality of a patent access and ends at the first occlusion (thrombosis).
Time frame
6, 12, 18, 24 and 36 months3
Incidence of graft infections
Time frame
6, 12, 18, 24 and 36 months4
Incidence of serious device-related adverse events
Time frame
12, 18, 24 and 36 monthsOther outcomes
1
Flow rate in graft (ultrasound)
Time frame
6, 12, 18, 24 and 36 months2
Peak Systolic Velocity Ratio at venous anastomosis (ultrasound)
Time frame
6, 12, 18, 24 and 36 months3
Pulsatility index (ultrasound) in graft and in outflow vein
Time frame
6, 12, 18, 24 and 36 monthsSponsors and contacts
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Source ClinicalTrials.gov