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
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
Treatments tested in this trial
- STARgraft (10401)
- Gore Propaten
Treatment groups
75 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov