Registration Trial of the Drug-coated Balloon for the Symptomatic Cerebral Atherosclerotic Stenosis

Официальное название

A PROSPECTIVE, MULTI-CENTER, OPEN-LABEL, SUPERIORITY, RANDOMIZED, CONTROLLED REGISTRATION TRIAL OF THE RAPAMYCIN NEUROVASCULAR BALLOON CATHETER FOR THE TREATMENT OF SYMPTOMATIC CEREBRAL ATHEROSCLEROTIC STENOSIS

Обзор

The purpose of the trail is to determine whether DCB is superior to conventional balloon in treating cerebral atherosclerotic stenosis

Вмешательства

• Устройство Rapamycin neurovascular Balloon Catheter
  Drug-coated balloon for the symptomatic cerebral atherosclerotic stenosis
• Устройство Conventional Balloon
  Conventional Balloon for the symptomatic cerebral atherosclerotic stenosis

Первичные конечные точки

• Target lesion restenosis rate at 6 month postoperative [Срок оценки: 180±30days]

Вторичные конечные точки (7)

• Technical succeed rate [Срок оценки: Intraoperation]
• Target vascular-related stroke or death at 30 days postoperatively [Срок оценки: 30±7days]
• Any stroke or death at 30 days postoperatively [Срок оценки: 30±7days]
• Target vascular-related stroke or death at 6 month postoperatively [Срок оценки: 180±30days]
• Any stroke or death at 6 month postoperatively [Срок оценки: 180±30days]
• Target vascular-related stroke or death at 12 month postoperatively [Срок оценки: 360±60days]
• Any stroke or death at 12 month postoperatively [Срок оценки: 360±60days]

Критерии участия

Incsion Criteria:

• Age 18 to 80 years old at informed consent signing.
• Symptomatic atherosclerotic stenosis of cerebrovascular arteries with ≥70% stenosis.
• Medication ineffective.
• modified Rankin Scale(mRS) score≤2.
• The subject or guardian is able to understand the purpose of the study, is willing to participate and has given written informed consent.

Критерии исключения

• History of acute ischemic stroke within 2 weeks;
• Stenosis due to non-atherosclerotic lesions such as arterial dissection, Moya-Moya disease and vasculitic disease;
• Target vessels complete occlusion or with thrombus in target vessels;
• Target vessel with severe calcification or distortion that making interventional device is difficult to place;
• History of stenting in the target artery;
• Target vessel restenosis following stenting or balloon angioplasty;
• Combined with other lesion with ≥70% stenosis in target vessel.
• Residual stenosis ≥50% or vessel dissection with obvious blood flow restriction occurs after predilation.
• Combined with intracranial tumour, arteriovenous malformation or aneurysm of the target vessel.
• History of intracranial hemorrhage within 90days.
• Presence of severe systemic diseases that cannot tolerate surgery, such as severe liver and kidney dysfunction;
• Contraindication to the use of anticoagulants and antiplatelet agents, such as sllergy to anticoagulants and antiplatelet agents, active bleeding or coagulation disorders;
• Allergic to contrast agents or rapamycin;
• Pregnant or lactating women;
• Participating or intending to participate in any other drug/device clinical trials;
• Life expectancy <1 year;
• Any other conditions that the investigator deems the patient unsuitable for enrollment.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 2 центра

• Tiantan Hospital Affiliated of Peking University — Пекин
• Huashan Hospital Affiliated of Fudan University — Шанхай

Идентификаторы

NCT: NCT06683118 · JUJI-2023-01-CIP-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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