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Идёт набор NCT06001827

SAVE-FistulaS: the SelfWrap-Assisted ArterioVEnous Fistulas Study

Без фазы С лечением Chronic Kidney Diseases End Stage Renal Disease Arteriovenous Fistula Hemodialysis Access Failure

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: SelfWrap Bioabsorbable Perivascular Wrap, Untreated AVF Control.
Кому может быть актуально
Состояния в реестре: Chronic Kidney Diseases, End Stage Renal Disease, Arteriovenous Fistula, Hemodialysis Access Failure. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

This is a prospective, randomized, multi-center clinical trial for chronic kidney disease (CKD) patients referred for creation of a new arteriovenous fistula (AVF) in order to assess the safety and effectiveness of SelfWrap, a bioabsorbable perivascular wrap.

Подробное описание

This is a multi-center, prospective, randomized, double-arm, single-blind, evaluator-blinded clinical trial for CKD patients referred for creation of a new arteriovenous fistula (AVF). This study will involve approximately 600 participants from up to 30 investigational sites, randomized 1:1 to treatment with the SelfWrap or the untreated AVF control (i.e. standard of care, SOC). Participants will be followed for a duration of 36 months.

Вмешательства

  • Устройство SelfWrap Bioabsorbable Perivascular Wrap
    SelfWrap is applied during arteriovenous fistula (AVF) creation surgery. It provides mechanical support to improve maturation and patency of AVFs.
  • Процедура Untreated AVF Control
    AVF creation surgery without any intervention

Первичные конечные точки

  • Unassisted Maturation by 180 days [Срок оценки: Assessed at up to 6 months]
  • Freedom from access-related adverse events through 30 days [Срок оценки: Assessed through 30 days]

Критерии участия

Критерии включения

  • Age of at least 18 years
  • Referred for creation of a new AVF
  • Willing and able to comply with study requirements, communicate with the study team, and attend follow up visits over a period of 36 months

Критерии исключения

  • Planned index procedure to revise or repair an existing fistula
  • Target artery inner diameter < 2.0 mm, as measured by ultrasound while the target arm is under tourniquet pressure and anesthesia
  • Target vein inner diameter < 2.0 mm, as measured by ultrasound while the target arm is under tourniquet pressure and anesthesia
  • Significant (at least 50%) stenosis at the target vein on the side of surgery (between the planned anastomosis site and the axillary vein), as diagnosed by preoperative ultrasound
  • Known central venous stenosis of at least 50% on the side of surgery
  • Presence of a stent or a stent graft within the access circuit
  • Known or suspected coagulation disorder that, in the opinion of the Investigator, puts too much risk on the patient for AVF creation
  • Known or suspected active infection at the time of surgery
  • Congestive heart failure NYHA class 4
  • Prior steal on the side of surgery;
  • Enrolled in another investigational drug, device, or biological study, or was previously enrolled in this study
  • Life expectancy less than 12 months
  • Expected to undergo kidney transplant surgery within 6 months of enrollment
  • Expected to undergo home hemodialysis
  • Females of childbearing potential (premenopausal and not surgically sterile) without documented current negative pregnancy test at screening
  • Presence of a comorbid condition that, in the opinion of the Investigator, may significantly confound the collection of safety and efficacy data in this study
  • Unwillingness or inability to give consent and/or comply with the study follow up schedule
  • Any health condition, which in the opinion of the Investigator, would interfere with the safety of the participant or the participant's ability to comply with the study.

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
Двойное слепое
Основная цель
Лечение

Центры проведения

США · 28 центров
  • AKDHC Bullhead City — Bullhead City
  • AKDHC Marana Surgery Center — Marana
  • Arizona Kidney Disease & Hypertension Centers (AKDHC) Phoenix Surgery Center — Phoenix
  • Banner University Medical Center — Tucson
  • Orange County Vascular Access Center — Garden Grove
  • Tallahassee Research Institute — Tallahassee
  • Lutheran Medical Group — Fort Wayne
  • Surgical Associates of Lexington — Lexington
  • … и ещё 20 центров

Идентификаторы

NCT: NCT06001827 · VENO-CIP002

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗