Registry of GORE® ACUSEAL Vascular Graft in Dialysis Access
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorW.L.Gore & Associates
About this trial
The goal of this observational study is to evaluate safety and performance of GORE® ACUSEAL Vascular Graft for the treatment of CKD in patients with ESRD in hemodialysis. The main questions it aims to answer are:
* Safety: Freedom from device-related infection adverse events at 24 months from device implant * Performance: Secondary patency at 24 months from device implant.
Participants, after informed consent is obtained, will be implanted with GORE® ACUSEAL Vascular Graft and followed for 24 months in standard of care, to evaluate safety and performance of the device.
Eligibility criteria
Qualifiers
The patient requires the creation of vascular access for hemodialysis secondary to a diagnosis of End-Stage Renal Disease and intends to use GORE® ACUSEAL Vascular Graft device for arteriovenous (AV) access.
Age ≥18 years at time of Informed Consent Form (ICF) signature.
Willingness of the patient to adhere to institutional standard of care follow-up.
Informed Consent Form (ICF) is signed by the patient.
Disqualifiers
The patient currently has a known or suspected systemic infection.
The patient is pregnant or breastfeeding.
The patient had a separate interventional or surgical vascular procedure within the study limb within 30 days prior to treatment with the GORE® ACUSEAL Vascular Graft device.
The patient had a previous documented (via imaging technique) and unsuccessfully treated ipsilateral central venous stenosis.
Trial design
Treatments tested in this trial
- GORE® ACUSEAL Vascular Graft
Treatment groups
72 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov