End Stage Renal Disease (ESRD)
Conditions
Keywords
Hemodialysis, Arteriovenous graft
Brief summary
The goal of this observational study is to collect long-term safety and performance data for the use of the EndoForce System for connecting a hemodialysis graft to a vein in patients with End Stage Renal Disease. This is not an experimental procedure or an experimental therapy. This means that the study device has been approved by the FDA.
Interventions
None listed
Sponsors
Phraxis, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient is ≥18 years of age. * Patient requires the creation of a vascular access graft for hemodialysis, secondary to a diagnosis of ESRD. * Patient is able to have the vascular access ePTFE graft placed in an upper arm. * Patient or his/her legal guardian understands the study and is willing and able to comply with the dialysis schedule and follow-up requirements. * Patient or his/her legal guardian provides written informed consent.
Exclusion criteria
* All contraindications for the EndoForce Connector System according to the IFU. * Patient is pregnant. * Patient is enrolled in another dialysis or vascular investigational study, without prior approval from the Sponsor.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of AVG Interventions to Maintain Patency | 2 years | The number of AVG interventions until access abandonment or through study completion. |
| Incidence of Treatment-Emergent Adverse Events | 2 years | All device and/or procedure-related events and all major adverse events that reasonably suggest the involvement of the EndoForce and that require or result in any of the following: death, emergent surgery, events requiring hospitalization, events requiring percutaneous interventions, vascular access infection requiring treatment, significant bleeding, pseudoaneurysm and serious adverse events. EndoForce migration, inadequate seal and leakage will also be collected acutely and at each in-person follow-up visit. |
| AVG Cumulative Patency | 2 years | The percentage of subjects free from loss of access of the study graft for hemodialysis. |
| AVG Primary Patency | 2 years | The percentage of subjects free from the first occurrence of either access thrombosis or an access procedure performed to maintain access patency. |
| Number of Participants with Acute Device Success | Through end of procedure | AV graft flow at the end of the procedure as determined by palpable graft thrill and/or audible bruit, without significant bleeding or emergent surgery. |
Countries
United States
Contacts
CONTACTJohn Zentgraf
PRINCIPAL_INVESTIGATORAri Kramer, MD
Spartanburg Regional Medical Center
Outcome results
None listed