Maturation of Arteriovenous Fistula With Automated Sonography Assessments Trial

Обзор

This is a prospective, multi-center, two-arm, randomized trial to quantify the performance of the EchoMark®/EchoSure® System for AVF diagnostic ultrasound when used under a protocol of biweekly use for assessing fistula maturation and reducing time to Clinical Maturation.

Вмешательства

• Устройство EchoMark/EchoSure
  Subjects assigned to the Diagnostic Arm will have the EchoMark implanted at the time of AVF creation. The subject will return every 2 weeks for a follow-up assessment to include an EchoSure scan until fistula maturation and/or permanent access use is achieved. The EchoSure scans are to be reviewed by the investigator(s) or delegated study staff and aid in the determination when a further assessment, including a physical exam, is required to determine cannulation clearance or if an intervention(s
• Процедура Standard of Care
  Subjects are assessed using standard of care per KDOQI guidelines, which includes a physical exam at the 2-week follow-up visit and at the 4-6-week follow-up visit. All follow-up visits will include an assessment of adverse events and medical history review to include all interventions, cannulation attempts, and laboratory results. If evaluation yields an abnormal finding, subjects will undergo a Duplex ultrasound assessment and treatment under the institution's standard of care. All SOC Arm sub

Первичные конечные точки

• Primary Safety Endpoint [Срок оценки: 6 months]
• Primary Effectiveness Endpoint [Срок оценки: 6 months]

Вторичные конечные точки (9)

• Difference between EchoSure and Duplex Flow Measurements [Срок оценки: 6 Months]
• EchoSure Depth Comparison [Срок оценки: 6 Months]
• EchoSure Diameter Comparison [Срок оценки: 6 Months]
• EchoMark/EchoSure System Technical Success [Срок оценки: 4 Months]
• CVC Removal [Срок оценки: 6 Months]
• Rate of Hospitalization [Срок оценки: 6 Months]
• AV Fistula Maturation Rate [Срок оценки: 6 Months]
• Total Cost of Care [Срок оценки: 6 Months]
• Freedom from Events through 30 and 90 Days [Срок оценки: 30 Days and 90 Days]

Критерии участия

Критерии включения

• 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 patient'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).
• CKD Stage 5 (eGFR less than 10) or ESRD subjects presenting for upper arm autologous arteriovenous fistula creation that is not transposed for hemodialysis access.
• Subjects who are currently on dialysis through a CVC or who imminently require dialysis (GFR <10).
• Vein diameter ≥ 2.5 mm at the antecubital fossa per vein mapping.
• Artery diameter ≥ 2.5 mm per vein mapping.
• Subject is not participating in another investigational clinical trial that has not met its primary end point. Participation in post-market registry is acceptable.

Критерии исключения

• CKD Stage 1-4 or subjects that do not require upper arm autologous arteriovenous fistula creation for hemodialysis access.
• 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 anticipated to convert to peritoneal dialysis or undergo a transplant within 6 months.
• Subjects who are pregnant, planning on becoming pregnant, or are breast feeding.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 21 центр

• Trinity Research Group — Dothan
• Southwest Kidney Institute — Phoenix
• AKDHC Medical Research Services — Phoenix
• AKDHC Center Tucson — Tucson
• Orlando Health Heart and Vascular Institute — Orlando
• Northwestern University — Chicago
• Kansas Nephrology Research Institute — Wichita
• Boston Medical Center — Boston
• … и ещё 13 центров

Идентификаторы

NCT: NCT06190717 · MAFASA-2023

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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