A First-In-Man Study to Assess Safety and Efficacy of Ultra High Pressure PTA Balloon ULTRAVIOLET in Treating A-V Fistula Stenosis

Официальное название

ULTRAVIOLET FIM_A First-In-Man Single Arm Prospective Single Center Study to Assess Safety and Efficacy of Ultra High Pressure PTA Balloon ULTRAVIOLET in Treating A-V Fistula Stenosis

Обзор

First-In-Man Single Arm Prospective Study to assess the safety and efficacy of ULTRAVIOLET UHP PTA balloon.

Подробное описание

First-In-Man Single Site study to assess safety and efficacy of ultra-high pressure PTA balloon called ULTRAVIOLET UHP PTA in treating resistant stenotic lesions in arterio-venous fistula of dialysis patients.

Вмешательства

• Устройство PTA balloon
  Angioplasty of a resistant stenotic lesion in the arterio-venous fistula

Первичные конечные точки

• Technical Success [Срок оценки: At the end of the procedure (up to 40 minutes)]
• Freedom from procedure-related complications after 1 month [Срок оценки: 1 month]

Вторичные конечные точки (7)

• Acute Device Success [Срок оценки: At the end of the procedure (up to 40 minutes)]
• Clinical Success [Срок оценки: At the end of the procedure (up to 40 minutes)]
• Procedural Surgery success [Срок оценки: At the end of hospitalization (assessed up to 5 days)]
• Target Lesion Primary Patency [Срок оценки: 1 month]
• Freedom from target lesion revascularization [Срок оценки: 1 month]
• Major Adverse Events (MAE) [Срок оценки: 1 month]
• Dialysis Circuit Patency [Срок оценки: 1 month]

Критерии участия

Критерии включения

• Patients able to understand the purpose of the study, voluntarily agree to participate and signed Informed Consent form
• Patients with impaired haemodialysis access due to narrowed lesions, as indicated by contrast or ultrasound or clinical diagnosis.
• Indications for percutaneous endovascular therapy with diameter stenosis >50% and fistula's hemodynamic showing abnormalities (thrombosis in the AVF, high venous pressure, re-circulation, abnormal physical examination, decrease in dialysis efficiency, decrease in blood flow through the vascular access)
• Target lesion is a resistant de novo or restenotic lesion
• The target lesion is located in the reflux vein from the anastomotic site of arteriovenous fistula (AVF) to the distal end of the subclavian vein (excluding the anastomotic site of AVF); if there are no target lesions, they should be treated with standard angioplasty balloon before treating the target lesion.

Критерии исключения

• Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrolment into this study;
• Patients who are actively participating in another drug or device investigational study, who have not completed the primary endpoint follow-up period;
• Patients who have undergone major surgical procedures (such as open chest surgery, head surgery) within 30 days before being enrolled in the study;
• Patients who plan to undergo major surgical procedures (such as open chest surgery, head surgery) within 30 days after being enrolled in the study;
• Immature AVF (not used for dialysis; due to insufficient inner diameter, inability to ensure successful puncture, and inadequate blood flow, this access has not been used for successful dialysis);
• AVF has been implanted with a stent.

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

Италия · 1 центр

• ASST Sette Laghi — Varese

Идентификаторы

NCT: NCT07330817 · CN-PER-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗