Standardized Procedure for Intracranial Drug-Eluting Stenting in the Treatment of Intracranial Atherosclerotic Stenosis

Официальное название

A Prospective, Multicenter, Registry Study to Evaluate the Safety, Efficacy, and Standardized Procedural Optimization of the Intracranial Drug-Eluting Stent System in Patients with Symptomatic Intracranial Atherosclerotic Stenosis

Обзор

The primary objective of this trial is to evaluate the Safety, Efficacy, and Standardized Procedural Optimization of the Intracranial Drug-Eluting Stent System in Patients with Symptomatic Intracranial Atherosclerotic Stenosis.

Подробное описание

The investigation is a prospective, multi-center clinical study. The trial is expected to enroll 300 subjects. The population for this study is subjects with intracranial atherosclerotic stenosis who are suitable candidates for stent angioplasty. Patients fulfilling all of the inclusion criteria and none of the exclusion criteria will be enrolled after they signed the informed consent form. The study consists of ten visits including preoperative screening, procedure date, 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years. The primary endpoints are stroke or death within 30 days after enrollment, plus any ischemic stroke or revascularization from the original culprit intracranial artery beyond 30 days through 12 months after procedure.

Вмешательства

• Устройство NOVA DES
  The NOVA stent is a sirolimus-eluting stent system designed for intracranial artery stenosis with a rapid exchangeable balloon

Первичные конечные точки

• Stroke or death within 30 days after enrollment, plus any ischemic stroke or revascularization from the original culprit intracranial artery beyond 30 days through 12 months after procedure. [Срок оценки: 1 year after procedure]

Вторичные конечные точки (12)

• Rate of any stroke (hemorrhagic/ischemic stroke) in the target blood supply area or all-cause death at 30 days after procedure [Срок оценки: 30 days after procedure]
• Rate of any stroke (hemorrhagic/ischemic stroke) in the non-target blood supply area or all-cause death at 30 days after procedure [Срок оценки: 30 days after procedure]
• Rate of TIA at 30 days, 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after procedure [Срок оценки: 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after procedure]
• Rate of any stroke (hemorrhagic/ischemic stroke) in the target blood supply area at 3, 6 months, 1, 2, 3, 4 years and 5 years after procedure [Срок оценки: 3, 6 months, 1, 2, 3, 4 years and 5 years after procedure]
• Rate of any stroke (hemorrhagic/ischemic stroke) in the non-target blood supply area at 3, 6 months, 1, 2, 3, 4 years and 5 years after procedure [Срок оценки: 3, 6 months, 1, 2, 3, 4 years and 5 years after procedure]
• Rate of death (vascular/ non-vascular death) at 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after procedure [Срок оценки: 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after procedure]
• Rate of symptomatic ISR and Revascularization at 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after procedure [Срок оценки: 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after procedure]
• Rate of modified Rankin Scale (mRS) at 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after procedure [Срок оценки: 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after procedure]
• EQ-5D score at 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after procedure [Срок оценки: 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after procedure]
• Rate of in-stent restenosis at 1, 2, 3, 4 years and 5 years after procedure (Optional) [Срок оценки: 1, 2, 3, 4 years and 5 years after procedure]
• Rate of Device defect [Срок оценки: within 5 years of whole trial]
• Rate of bleeding events at 1 years after procedure [Срок оценки: 1 year after procedure]

Критерии участия

Критерии включения

• Males or females between 18 and 80 years of age
• Symptomatic intracranial arteriosclerosis stenosis with reference diameter 2.25-4.00mm
• Intracranial artery stenosis ( ≥70%) conformed by DSA
• Those who voluntarily participate in the study and sign informed consent form

Критерии исключения

• Those who have surgery within previous 30 days or plan to perform major surgery in the next 90 days (surgery grade 3 and above);
• Subjects of acute hemorrhagic stroke within 3 months;
• The baseline mRS of disabling stroke is more than 3;
• The target vessel is severely calcified and closely related to stenosis;
• Non-atherosclerotic diseases (e.g. arterial dissection, Moya Moya disease, vascular inflammatory lesions caused by infection, autoimmune diseases, post-irradiation, postpartum status; developmental or genetic abnormalities such as fibromuscular dysplasia, sickle cell anemia, suspected vasospasm);
• It is suspected that the ischemic event is due to embolism or arterial embolism from the extracranial segment (including ipsilateral chest or neck vascular occlusive disease) or potential cardiogenic embolism (e.g. atrial fibrillation, mitral stenosis, patent foramen ovale, left ventricular thrombus, myocardial infarction within 6 weeks, etc.);
• The presence of a >50% stenosis in the main blood supply artery of the target vessel. For example, when the lesion is located in the middle cerebral artery, the ipsilateral internal carotid artery stenosis by over 50% should be excluded; when the lesion is located in the basilar artery, the dominant side vertebral artery stenosis >50% should be excluded;
• There are intracranial tumors, or intracranial arteriovenous malformations;
• Those who are allergic to heparin, aspirin, clopidogrel, contrast agents, anesthetics, and stent components;
• Pregnant and lactating women
• Those who are unable to complete follow-up because of mental illness, cognitive or emotional disorders;
• Inapplicable for this study at the investigators' viewpoints.

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

• The first affiliated hospital of zhengzhou university — Чжэнчжоу

Идентификаторы

NCT: NCT06857058 · SN-NOVA II SOP-202501

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗