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Completed

NCT Number: NCT04896476

Prospective Feasibility Study Evaluating EchoMark LP Placement and EchoSure Measurements for Subjects Requiring Arteriovenous Fistulae

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.

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Key information

Conditions

Kidney Diseases Arteriovenous Fistula Arteriovenous Malformations Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Fistula Male Urogenital Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Urogenital Diseases Urologic Diseases Vascular Diseases Vascular Fistula Vascular Malformations

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Trinity Research Group, Dothan, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males or non-pregnant, non-breastfeeding females ≥ 18 years of age but < 85 years of age at the time of informed consent
  • Subject is able and willing to provide written informed consent prior to receiving any non-standard of care, protocol specific procedures
  • Subject is willing and capable of complying with all required follow-up visits
  • 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
  • Subject has an estimated life expectancy > 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.

Treatment and study plan

EchoMark / EchoSure

Device

The EchoMark is to be secured a minimum of 3 cm away from the anastomosis.

The follow-up EchoSure scans will be conducted by the designated EchoSure user without the investigator and without the sonographer/RVT conducting the Duplex exam in the room, either during the routine work-up prior to the surgeon seeing the patient or after. The EchoSure results for flow, and vessel depth and diameter are shown as numerical values on the screen of the EchoSure device.

Primary outcomes

  1. Primary Safety Endpoint

    Time frame: 30 Days

    Composite of new major device related adverse events (MAEs) at 30 days post EchoMark implantation, as adjudicated by the Clinical Events Committee (CEC) including:

    • Device or procedure-related death
    • Device related infection
    • Device related interventions
    • Device related hospitalizations
    • Fistula failure
    • Fistula rupture
    • Aneurysm

  2. Primary Feasibility Endpoint

    Time frame: 4 Months

    Rate of Technical Success defined as the successful implantation of the EchoMark implant. Technical success will be assessed from baseline to 4 months.

  3. 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.

    Time frame: 4 Months

    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.

Other outcomes

  1. Comparison of EchoSure and Duplex Measurements Using Percentages

    Time frame: 6 Months

    Bland Altman using percentages will assess the agreement between two measurements.

    Only duplex images that pass the CoreLab quality control check will be included in the assessment.

    The results will be calculated as a percent difference between the two measurements with a value of zero corresponding to exact agreement.

  2. Comparison of EchoSure and Duplex Measurements of Diameter

    Time frame: 6 Months

    Bland Altman using percentages will assess the agreement between two measurements.

    Only duplex images that pass the CoreLab quality control check will be included in the assessment.

    The results will be calculated as a percent difference between the two measurements with a value of zero corresponding to exact agreement.

  3. Comparison of EchoSure and Duplex Measurements of Depth

    Time frame: 6 Months

    Bland Altman using percentages will assess the agreement between two measurements.

    Only duplex images that pass the CoreLab quality control check will be included in the assessment.

    The results will be calculated as a percent difference between the two measurements with a value of zero corresponding to exact agreement.

  4. Comparison of EchoSure Depth Measurements to Independent Reviewer Measured Depth Results.

    Time frame: 4 Months

    Bland Altman using percentages will assess the agreement between two measurements.

    The results will be calculated as a percent difference between the two measurements with a value of zero corresponding to exact agreement.

  5. Time to Radiographic Maturation

    Time frame: 12 Months

    defined as the number of days from baseline procedure to date of radiographic maturation (date of ultrasound imaging, as adjudicated by the CEC). Radiographic maturation is defined as a fistula with volume flow of 500mL/min and 5mm diameter.

  6. Time to Clinical Maturation

    Time frame: 12 Months

    defined as the number of days from baseline procedure to date of clinical maturation. Clinical maturation is defined as 75% of dialysis sessions with successful 2 needle cannulation. Date of clinical maturation is defined as first date of the 4-week window when clinical maturation is achieved.

  7. Radiographic Maturation Success Rate

    Time frame: 12 Months

    defined as the percentage of subjects that achieve radiographic maturation (as determined by the physician and adjudicated by the CEC) by end of study. Radiographic maturation is defined as a fistula with 500mL/min and 5mm diameter.

  8. Clinical Maturation Success Rate

    Time frame: 12 Months

    defined as the percentage of subjects that achieve clinical maturation by end of study. Date of clinical maturation is defined as first date of the 4-week window when clinical maturation is achieved.

  9. Number of Patients With 6-Month Patency

    Time frame: 6 Months

    defined by the status (yes/no) of an arteriovenous dialysis access with detectable blood flow through and beyond the anastomosis shown by either an imaging modality or physical examination (presence of a palpable thrill or audible bruit along some point of the arteriovenous dialysis access beyond the arteriovenous anastomosis).

  10. Number of Patients With 12-Month Patency

    Time frame: 12 Months

    defined by the status (yes/no) of an arteriovenous dialysis access with detectable blood flow through and beyond the anastomosis shown by either an imaging modality or physical examination (presence of a palpable thrill or audible bruit along some point of the arteriovenous dialysis access beyond the arteriovenous anastomosis).

  11. Occurrence of Events Occurring Within 30 Days of Implantation That Require Reinterventions (Open or Endovascular), Hospitalizations, or Prolongation of Existing Hospitalization.

    Time frame: 30 Days

  12. 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.

    Time frame: 12 Months

  13. Occurrence of the Reported Inability to Cannulate Fistula Beginning Once the Fistula is Deemed Radiographically and Clinically Mature to 12 Months.

    Time frame: 12 Months

  14. Occurrence of Events of the Development of Steal Syndrome From Baseline to 12 Months.

    Time frame: 12 Months

  15. Occurrence of Events of Bleeding Requiring Surgical Intervention (Including PRBC Transfusion) From Baseline to 12 Months.

    Time frame: 12 Months

  16. Occurrence of Events of Infiltration Requiring Procedural Intervention From Baseline to 12 Months.

    Time frame: 12 Months

  17. Occurrence of Events of Hematoma Requiring Procedural Intervention From Baseline to 12 Months.

    Time frame: 12 Months

  18. Occurrence of Events of the Inability to Use the EchoSure Component of the System From Baseline to 4 Months

    Time frame: 4 Months

    Due to:

    • Migration of the EchoMark device
    • Early resorption of the EchoMark device as defined as breakdown of the EchoMark shape prior to 4 months from index procedure.

  19. Occurrence of Events of Pain Related to the Study Devices From Baseline to 12 Months

    Time frame: 12 Months

  20. Occurrence of Events of Infection (Not Limited to Infection Requiring Implant Explanation) From Baseline to 12 Months

    Time frame: 12 Months

  21. 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

    Time frame: 12 Months

  22. Composite of New Major Device Related Adverse Events (MAEs) at 12 Months Post EchoMark LP Implantation, as Adjudicated by the Clinical Events Committee (CEC).

    Time frame: 12 Months

    The proportion of subjects with device success and free from device- and/or procedure related

    SAEs (per CEC adjudication) at 12 months including:

    • Device or procedure-related death
    • Device related infection
    • Device related interventions
    • Device related hospitalizations
    • Fistula failure
    • Fistula rupture
    • Aneurysm

Sponsors and collaborators

Lead sponsor

Sonavex, Inc.

Industry

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2026
First posted
May 21, 2021
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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