Xeltis Hemodialysis Access (aXess) Conduit: aXess-E Study

Официальное название

Prospective, Non-randomized Feasibility Study to Confirm the Safety and Performance of the Xeltis Hemodialysis Access Conduit: aXess-E Study

Обзор

A prospective, single arm, non-randomized feasibility study to confirm the safety and performance of the Xeltis Hemodialysis Access conduit, aXess-E, in subjects older than 18 years with end-stage renal disease, who plan to undergo hemodialysis for at least the first 6 months after study access creation.

Вмешательства

• Устройство aXess-E conduit
  The aXess-E conduit is a sterile, regenerative biodegradable polymer-based vascular conduit, 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-E conduit is able to support both straight and loop configurations and may be implanted in the upper arm and forearm.

Первичные конечные точки

• Primary Patency rate [Срок оценки: 6 months]
• Freedom from device-related Serious Adverse Event (SAE) [Срок оценки: 6 months]

Вторичные конечные точки (12)

• Implantation success rate [Срок оценки: 1 day, from moment of implant until end of procedure day]
• Primary patency rate [Срок оценки: 6, 12, 18, and 24 months]
• Primary assisted patency rate [Срок оценки: 6, 12, 18, and 24 months]
• Secondary patency rate [Срок оценки: 6, 12, 18, and 24 months]
• Functional patency rate [Срок оценки: 6, 12, 18, and 24 months]
• Time (expressed in months) to first intervention and to access abandonment [Срок оценки: 24 months]
• Rate of access-related interventions required to achieve/maintain patency [Срок оценки: 6, 12, 18, and 24 months]
• Freedom from device-related SAE [Срок оценки: 12, 18, and 24 months]
• Rate of access site infections [Срок оценки: 6, 12, 18, and 24 months]
• Proportion of hemodialysis sessions completed via central venous catheter (CVC) during the first 12 months of access creation and access cannulation, irrespective of access abandonment [Срок оценки: 24 months]
• Time to first cannulation [Срок оценки: 24 months]
• Following first cannulation, number of days with CVC in situ (catheter contact time) irrespective of access abandonment [Срок оценки: 12 months]

Критерии участия

Критерии включения

• Subjects with end-stage renal disease (ESRD) who require placement of an Arteriovenous Graft (AVG) in the upper extremity to start or maintain hemodialysis therapy
• At least 18 years of age at screening
• Suitable anatomy (e.g. a target vein with a minimum diameter of 5mm) for the implantation of an aXess-E conduit
• The patient has been informed about the nature of the study, understands and agrees to its provisions, and has personally 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 (New York Heart Association (NYHA) Functional Class IV and/or Ejection Fraction (EF) <25%), myocardial infarction within six months of study enrolment, ventricular tachyarrhythmias requiring continuing treatment, or unstable angina
• Uncontrolled or poorly controlled diabetes
• Abnormal blood values that could influence patient recovery and or/ conduit 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 conduit implantation
• Previous dialysis access conduit in the operative limb unless the aXess-E conduit can be placed more proximally than the previous failed conduit
• Previous enrolment in this study
• Subject is participating in another study
• Pregnant or breastfeeding woman or woman in fertile period not taking adequate contraceptives
• Any other condition which, in the judgement 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-E conduit (e.g. target vein and/or artery diameter smaller than anticipated; severe calcification)

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Португалия · 1 центр

• Hospital de Santa Maria — Lisbon

Сербия · 1 центр

• Kliničko bolnički centar Zvezdara Klinika za Interne Bolesti — Belgrade

Идентификаторы

NCT: NCT06329310 · XEL-CR-14

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗