Investigating the Safety and Clinical Performance of Eight iVascular Devices for Endovascular Intervention in Renal, Iliac or Femoral Arteries

Официальное название

A Prospective PMCF Study Investigating the Safety and Clinical Performance of the Oceanus 18 and Oceanus 35 Balloon Dilatation Catheters, the Luminor 18 and Luminor 35 Drug Coated Balloons, the Restorer Peripheral Stent System, the iVolution Pro Peripheral Self-Expanding Stent System, the iCover Covered Peripheral Stent System and the Sergeant Peripheral Support Catheter for Endovascular Interventions.

Обзор

The rationale of this study is to confirm and support the clinical safety and performance of any of these products in a real-world population of 209 patients who underwent an endovascular intervention within standard-of-care of the iliacofemoral artery and renal artery, using at least one of the investigational products from iVascular.

Вмешательства

• Процедура endovascular intervention
  endovascular intervention

Первичные конечные точки

• Freedeom from SAEs and SADEs (Primary Safety Endpoint) [Срок оценки: during procedure and up to 2 years after procedure]
• Technical success rate (Primary Efficacy Endpoint) [Срок оценки: during procedure]

Вторичные конечные точки (5)

• General physician appraisal of the devices by means of rating scale [Срок оценки: during procedure]
• General physician appraisal of the devices by means of rating scale for the Luminor 18, Luminor 35, Oceanus 18 and Oceanus 35 [Срок оценки: during procedure]
• General physician appraisal of the devices by means of rating scale for the Restorer, iVolution pro, iCover [Срок оценки: during procedure]
• General physician appraisal of the devices by means of rating scale for the Sergeant [Срок оценки: during procedure]
• Explorative endpoint [Срок оценки: up to 2 years after procedure]

Критерии участия

Критерии включения

• Corresponding to the CE-mark indications/contra-indications and according to the IFU of the device.
• Patient is >18 years old.
• Patient understands the nature of the procedure and provides written informed consent prior to enrollment in the study.
• Target lesion(s) is/are located in renal, iliac or femoral arteries.
• Patient is eligible for treatment with the Oceanus 18 Balloon Dilatation Catheter and/or the Oceanus 35 Balloon Dilatation Catheter and/or the Luminor 18 Drug Coated Balloon and/or the Luminor 35 Drug Coated Balloon and/or the Restorer Peripheral Stent System and/or the iVolution pro Peripheral Self-Expanding Stent System and/or the iCover Covered Peripheral Stent System and/or the Sergeant Peripheral Support Catheter as described in IFU for each device.

Критерии исключения

• Anatomy or size of vessels that will not allow appropriate usage of the investigational devices, following IFU of the investigational devices.
• Known contraindication and/or allergy to (a component of) an investigational device.
• Pregnant women and women with childbearing potential not taking adequate contraceptives or currently breastfeeding.
• Life expectancy of less than 12 months.
• Any planned surgical intervention/procedure within 30 days after the study procedure.
• Any patient considered to be hemodynamically unstable at onset of the procedure.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Франция · 6 центров

• CH Henri Duffaut — Avignon
• Clinique Synergia Ventoux — Carpentras
• Polyclinique Inkermann — Niort
• L'Hôpital Privé Des Côtes D'Armor — Plérin
• Hôpital d'instruction des Armées Sainte Anne — Toulon
• Hôpital Privé Toulon Hyeres St. Jean — Toulon

Идентификаторы

NCT: NCT05902923 · FCRE-220209

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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