A Prospective Clinical Evaluation of the Total Vascular Access (TVA) FLEX-1 Device Protocol FLEX-1-001
Not Applicable
Completed
- Conditions
- Chronic Kidney Disease (CKD)
- Interventions
- Device: Endovascular AVF (EndoAVF)
- Registration Number
- NCT02119845
- Lead Sponsor
- TVA Medical Inc.
- Brief Summary
The primary objective of this clinical study is to evaluate the preliminary safety and effectiveness of using the FLEX-1 device for the creation of an arteriovenous fistula (AVF) in patients requiring chronic hemodialysis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
Inclusion Criteria
- Eligible for a native surgical arteriovenous fistula, as determined by the treating physician.
- Adult (age >18 years old).
- Advanced chronic kidney disease (CKD), stage 4 or 5 electing for hemodialysis.
- Written informed consent obtained
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Endovascular AVF (EndoAVF) Endovascular AVF (EndoAVF) The FLEX System will be used to endovascularly create a fistula in CKD patients who require hemodialysis vascular access.
- Primary Outcome Measures
Name Time Method Adverse Events 6 months The safety of the FLEX-1 system based on the overall complication rates derived from adverse event data.
- Secondary Outcome Measures
Name Time Method Access Functionality 6 Months The functionality of the AVF will be measured based on use of the AVF with two needles for at least 75% of dialysis sessions over a 4-week period following at least a one month maturation period.
Trial Locations
- Locations (1)
Italian Hospital
🇵🇾Asuncion, Paraguay