N/A
N=20
Prospective Feasibility Study Evaluating EchoMark LP Placement and EchoSure Measurements for Subjects Requiring Arteriovenous Fistulae
Kidney Diseases · Arteriovenous Fistula
Bottom Line
View on ClinicalTrials.gov: NCT04896476 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcome: Primary: Primary Safety Endpoint — 0 MAES within 30 days post baseline visit
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- EchoMark / EchoSure (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sonavex, Inc.
- Primary completion
- Oct 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Safety Endpoint |
— | — |
| PRIMARY Primary Feasibility Endpoint |
20 | — |
| PRIMARY Rate of Technical Success Defined as the Successful Ability to Determine Blood Flow, Diameter, and Depth Measurements Using the EchoSure Diagnostic Ultrasound System. Technical Success Will be Assessed From Baseline to 4 Months. |
270 | — |
Summary
Multi-center trial to assess the feasibility and safety of the EchoMark LP and the EchoMark diagnostic ultrasound system for assessing AV fistula blood flow, diameter, and depth.
Eligibility Criteria
Inclusion Criteria
- Males or non-pregnant, non-breastfeeding females ≥ 18 years of age but 18 months
- Subject is ambulatory (cane or walker are acceptable)
- Subjects presenting for upper arm autologous arteriovenous fistula creation
- Vein diameter > 2.5 mm at the antecubital fossa via imaging
- Artery diameter > 3 mm via imaging
- Subject is not participating in another investigational clinical trial that has not met its primary endpoint. Participation in a post-market registry is acceptable.
Exclusion Criteria
- Subjects receiving a forearm fistula.
- Subject has history of Steal Syndrome.
- Subject who is immunocompromised or immunosuppressed.
- Subject has had three previous failed AV fistulae for hemodialysis access
- Subjects expecting to undergo major surgery within 60 days from the EchoMark implantation.
- Known or suspected active infection on the day of the index procedure.
- Subjects who had infection(s) in the 30-day window prior to EchoMark placement to reduce the likelihood of partially treated infections that can seed the device and fistula
- Subjects with diagnosed bleeding disorder, thrombocytopenia (platelet count <50,000), hypercoagulability, and history of recurrent deep vein thrombosis not related to AV access
- Subjects with active malignancy
- Subjects with a history of poor compliance with the dialysis protocol
- Subjects with a known or suspected allergy to any of the device materials
- Subjects with an existing fistula or graft
- Subjects who are pregnant, plan to become pregnant, or are breastfeeding.
Data sourced from ClinicalTrials.gov (NCT04896476). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.