Clinical trial NCT04896476: Prospective Feasibility Study Evaluating EchoMark LP Placement and EchoSure Measurements for Subjects Requiring Arteriovenous Fistulae
Official title: Prospective Feasibility Study Evaluating EchoMark LP Placement and EchoSure Measurements for Subjects Requiring Arteriovenous Fistulae
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Kidney Diseases
Arteriovenous Fistula
Lead sponsor: Sonavex, Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2021-05-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: This is a prospective, multi-center, single-arm, non-blinded clinical trial designed to evaluate the feasibility and safety of the EchoMark and the EchoSure in subjects undergoing new upper arm autologous arteriovenous fistula creation who require hemodialysis. All subjects will provide informed consent prior to undergoing any study procedures. The study will consists of multiple follow-up visits during the 52 week duration. Subjects are able to re-consent and remain in follow-up for an additional year.

Eligibility criteria: Inclusion Criteria:

1. Males or non-pregnant, non-breastfeeding females ≥ 18 years of age but \< 85 years of age at the time of informed consent
2. Subject is able and willing to provide written informed consent prior to receiving any non-standard of care, protocol specific procedures
3. Subject is willing and capable of complying with all required follow-up visits
4. Subject and/or Care Team agree that the distance and transportation resources from the subject's home to the clinic are reasonable for study participation and compliance
5. Subject has an estimated life expectancy \> 18 months
6. Subject is ambulatory (cane or walker are acceptable)
7. Subjects presenting for upper arm autologous arteriovenous fistula creation
8. Vein diameter \> 2.5 mm at the antecubital fossa via imaging
9. Artery diameter \> 3 mm via imaging
10. 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:

1. Subjects receiving a forearm fistula.
2. Subject has history of Steal Syndrome.
3. Subject who is immunocompromised or immunosuppressed.
4. Subject has had three previous failed AV fistulae for hemodialysis access
5. Subjects expecting to undergo major surgery within 60 days from the EchoMark implantation.
6. Known or suspected active infection on the day of the index procedure.
7. 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
8. Subjects with diagnosed bleeding disorder, thrombocytopenia (platelet count \<50,000), hypercoagulability, and history of recurrent deep vein thrombosis not related to AV access
9. Subjects with active malignancy
10. Subjects with a history of poor compliance with the dialysis protocol
11. Subjects with a known or suspected allergy to any of the device materials
12. Subjects with an existing fistula or graft
13. Subjects who are pregnant, plan to become pregnant, or are breastfeeding.

Primary outcomes:
measure: Primary Safety Endpoint
timeFrame: 30 Days
measure: Primary Feasibility Endpoint
timeFrame: 4 Months
measure: 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.
timeFrame: 4 Months
Secondary outcomes:
Other outcomes:
measure: Comparison of EchoSure and Duplex Measurements Using Percentages
timeFrame: 6 Months
measure: Comparison of EchoSure and Duplex Measurements of Diameter
timeFrame: 6 Months
measure: Comparison of EchoSure and Duplex Measurements of Depth
timeFrame: 6 Months
measure: Comparison of EchoSure Depth Measurements to Independent Reviewer Measured Depth Results.
timeFrame: 4 Months
measure: Time to Radiographic Maturation
timeFrame: 12 Months
measure: Time to Clinical Maturation
timeFrame: 12 Months
measure: Radiographic Maturation Success Rate
timeFrame: 12 Months
measure: Clinical Maturation Success Rate
timeFrame: 12 Months
measure: Number of Patients With 6-Month Patency
timeFrame: 6 Months
measure: Number of Patients With 12-Month Patency
timeFrame: 12 Months
measure: Occurrence of Events Occurring Within 30 Days of Implantation That Require Reinterventions (Open or Endovascular), Hospitalizations, or Prolongation of Existing Hospitalization.
timeFrame: 30 Days
measure: Occurrence of Events of Reported Reduction of Blood Flow That Prevents the Ability to Cannulate or Requires Further Assessment and/or Intervention From Baseline Procedure to 12 Months.
timeFrame: 12 Months
measure: Occurrence of the Reported Inability to Cannulate Fistula Beginning Once the Fistula is Deemed Radiographically and Clinically Mature to 12 Months.
timeFrame: 12 Months
measure: Occurrence of Events of the Development of Steal Syndrome From Baseline to 12 Months.
timeFrame: 12 Months
measure: Occurrence of Events of Bleeding Requiring Surgical Intervention (Including PRBC Transfusion) From Baseline to 12 Months.
timeFrame: 12 Months
measure: Occurrence of Events of Infiltration Requiring Procedural Intervention From Baseline to 12 Months.
timeFrame: 12 Months
measure: Occurrence of Events of Hematoma Requiring Procedural Intervention From Baseline to 12 Months.
timeFrame: 12 Months
measure: Occurrence of Events of the Inability to Use the EchoSure Component of the System From Baseline to 4 Months
timeFrame: 4 Months
measure: Occurrence of Events of Pain Related to the Study Devices From Baseline to 12 Months
timeFrame: 12 Months
measure: Occurrence of Events of Infection (Not Limited to Infection Requiring Implant Explanation) From Baseline to 12 Months
timeFrame: 12 Months
measure: Occurrence of Events of Infection Confirmed by Either Implant Explanation or Purulent Fluid on Pathologic Assessment During Incision and Drainage Beginning at Baseline to 12 Months
timeFrame: 12 Months
measure: Composite of New Major Device Related Adverse Events (MAEs) at 12 Months Post EchoMark LP Implantation, as Adjudicated by the Clinical Events Committee (CEC).
timeFrame: 12 Months
Locations:
city: Dothan
country: United States
facility: Trinity Research Group
state: Alabama
city: Peoria
country: United States
facility: SKI Vascular Center
state: Arizona
city: Flint
country: United States
facility: Michgan Vascular Center
state: Michigan
city: Charlotte
country: United States
facility: Surgical Specialist of Charlotte
state: North Carolina
Study officials:
References: