Набор по приглашению NCT06494631

Xeltis Hemodialysis Access Graft (aXess) US Study

Без фазы С лечением End Stage Renal Disease

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: Xeltis Hemodialysis Access (aXess) graft.
Кому может быть актуально: Состояния в реестре: End Stage Renal Disease. 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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Официальное название

Clinical Study to Assess the Safety and Performance of the Xeltis Hemodialysis Access Graft

Обзор

A multi-center, prospective, single-arm, non-randomized, staged, pivotal clinical study to evaluate the safety and performance of the aXess graft in subjects aged 18 and above, diagnosed with end-stage kidney disease, and possessing an estimated glomerular filtration rate (eGFR) less than 20 ml/min, who intend to undergo hemodialysis but are considered unsuitable candidates for fistula creation by the investigating surgeon.

Вмешательства

Устройство Xeltis Hemodialysis Access (aXess) graft
The aXess graft is a sterile, restorative biodegradable polymer-based vascular graft, consisting of a tubular structure with a 6mm inner diameter. It is comprised of a highly porous polymer matrix and an embedded electropolished nitinol reinforcement layer (Strain Relief System). The aXess graft is able to support both straight and loop configurations and may be implanted in the upper arm and forearm.

Первичные конечные точки

Secondary patency rate in survivors [Срок оценки: 12 months]
Rate of device related infections and bleeding [Срок оценки: 12 months]

Вторичные конечные точки (10)

Freedom from device-related SAE [Срок оценки: Discharge, 1, 3, 6, 12, 18, 24, and 60 months]
Implantation success rate [Срок оценки: 1 day, from moment of implant until discharge]
Patency (primary, primary assisted, secondary, and functional) rates [Срок оценки: 6, 12, 18, 24, and 60 months]
Time to first intervention and to access abandonment [Срок оценки: 60 months]
Rate of access-related interventions required to achieve/maintain patency [Срок оценки: 6, 12, 18, 24, 60 months]
Incidence rate of access site infections [Срок оценки: 6, 12, 18, 24, and 60 months]
Proportion of hemodialysis sessions completed via a central venous catheter (CVC) during the first 12 months of access creation and access cannulation, irrespective of access abandonment [Срок оценки: 12 months]
Time to the first cannulation [Срок оценки: 12 months]
Following the first cannulation, the number of days with CVC in situ (catheter contact time) during the first 12 months, irrespective of access abandonment [Срок оценки: 12 months]
Rate of peri-reintervention vascular injuries [Срок оценки: 6 months]

Критерии участия

Критерии включения

Subjects with end-stage renal disease (ESRD) who require placement of an AVG in the upper extremity to start (within the first 6 months of follow-up) or maintain hemodialysis therapy and are deemed unsuitable for fistula creation by the investigational surgeon.
At least 18 years of age at screening.
Suitable anatomy (e.g. a target vein with a minimum diameter of 4mm) for the implantation of an aXess graft
The patient has been informed about the nature of the study, agrees to its provisions, and has provided written informed consent.
The patient has been informed and agrees to pre- and post-procedure follow-up.
Life expectancy of at least 12 months.

Критерии исключения

History or evidence of severe cardiac disease (NYHA Functional Class IV and/or EF <25%), myocardial infarction within 6 months of study enrolment, ventricular tachyarrhythmias requiring continuing treatment, or unstable angina.
Uncontrolled or poorly controlled diabetes in the opinion of the investigator. Recommended standards of A1c level <8% / 183 mg/dl / 10.2 eAG.
Abnormal blood values (e.g., leukopenia with white blood cell count (WBC) <4,000/mm³ and/or anemia with Hemoglobin <8g/dL and/or thrombocytopenia <100,000/mm³) that could influence patient recovery and or/ graft hemostasis.
Reduced liver function, defined as: >2x the upper limit of normal for serum bilirubin, International Normalized Ratio (INR) >1.5 or prothrombin time (PT) >18 seconds.
Any active local or systemic infection.
Known heparin-induced thrombocytopenia.
Known active bleeding disorder and/or any coagulopathy or thromboembolic disease.
Allergies to study device (nitinol) or agents/medication, such as contrast agents or aspirin, that can't be controlled medically.
Anticipated renal transplant within 6 months.
Known or suspected central vein obstruction on the side of planned graft implantation.
Previous dialysis access graft in the operative limb, unless the aXess graft can be placed more proximally than the previously failed graft.
Previous enrollment in this study.
Subject is participating in another study.
A female who is breastfeeding or of childbearing potential with a positive pregnancy test or not using adequate contraception.
Any other condition which, in the judgment of the investigator, would preclude adequate evaluation for the safety and performance of the study conduit.

Intra-operative exclusion criteria:

1\. Unsuitable anatomy to implant the aXess graft (e.g., target vein and/or artery diameter not suitable; severe calcification).

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

Здоровые добровольцы: Нет