ACOART AVF RENEW: A Post Market Clinical Study

Официальное название

A Post Market Clinical Study to Evaluate the Safety and Efficacy of the Acotec Drug-coated Balloon for the Treatment of the Obstructive Lesions in the Native Arteriovenous Dialysis Fistuae(AVF)

Обзор

The objective of this prospective，multi-center，single arm study is to obtain further data on the safety and performance of the Acotec Orchid＆Dhalia Drug-coated Balloon catheters for the treatment of for the obstructive lesions in the native Arteriovenous Dialysis Fistulae (AVF).

Вмешательства

• Устройство DCB catheter
  Trade name of DCB catheter：Acoart Orchid＆Dhalia

Первичные конечные точки

• Target Lesion Primary Patency Rate [Срок оценки: 6 months]
• Serious Adverse Event Rate [Срок оценки: 30 days]

Вторичные конечные точки (2)

• Target Lesion Primary Patency Rate [Срок оценки: 12 months，24 months]
• All-cause mortality Rate [Срок оценки: 24 months]

Критерии участия

Критерии включения

• Patient is ≥18 and ≤85 years of age
• The target AV fistula has undergone successful dialysis for at least 1 time
• Patient has a de novo and/or non-stented restenotic lesion located in the outflow vein（Arteries and Central Vein are excluded）
• Patient has a de novo and/or non-stented restenotic lesion（≥50% stenosis）and at least one of the following occurs：

• The physical examination was abnormal
• Significant increase in dynamic venous pressure
• Blood flow decreased significantly
• Patient has a target lesion or a tandem lesion that is ≤ 100 mm in length
• Patient underwent successful crossing of the target lesion with the guide wire and pre-dilatation with a PTA balloon defined as:

• Residual stenosis of ≤ 30% AND
• Absence of a flow limiting dissection (Grade ≥C) or perforation
• Patient provides written informed consent prior to enrollment in the study

Критерии исключения

• Women who are breastfeeding, pregnant, or are intending to become pregnant, or men intending to father children
• Dialysis access is located in the lower extremity
• More than one lesion
• Patient with hemodynamically significant central venous stenoses
• Patient has presence of a stent located in the target AV access circuit
• Patient has undergone prior intervention of access site within 30 days of index procedure
• Patient with target AVF or access circuit which previously had or currently has a plan to surgery
• Patient who cannot receive recommended antiplatelet and/or anticoagulant therapy
• Patients undergoing immunotherapy or suspected/confirmed vasculitis
• Patients with a history of coagulation dysfunction, thrombocytopenic purpura or RH-negative blood type
• Patient has an infected AV access or systemic infection
• Patient has a life expectancy of <24 months
• Patient is anticipating a kidney transplant or with anticipated conversion to peritoneal dialysis
• Patient has a co-morbid condition that, in the judgment of the Investigator, may cause him/her to be non-compliant with the protocol or confound the data interpretation
• Patient is enrolled in another investigational drug, device, or biologic study and has not completed the primary endpoint, or was previously enrolled in this study

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

Китай · 1 центр

• Beijing Haidian Hospital — Пекин

Идентификаторы

NCT: NCT06205576 · ACOART AVF RENEW

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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