Flow-diverting Devices for the Treatment of Middle Cerebral Artery Bifurcation Aneurysms

Официальное название

A Prospective Randomized Controlled Trial of Flow-diverting Devices for the Treatment of Middle Cerebral Artery Bifurcation Aneurysms

Обзор

The goal of this clinical trial is to learn if flow diverter (FD) offers advantages over conventional stent-assisted coiling in the treatment of middle cerebral artery (MCA) bifurcation aneurysms . It will also learn about the safety of flow diverter (FD) treatment. The main questions it aims to answer are: Does flow diverter (FD) treatment improves the rate of complete aneurysm occlusion and patients' neurological function? Does flow diverter (FD) treatment loweres the probability of aneurysm recurrence and the occurrence of complications? Researchers will compare FD to a conventional stent-assisted coiling to see if FD treatment works better to treat MCA bifurcation aneurysms. Participants will: Undergo stent-assisted coiling or flow diverter treatment Take pre-operative and pre-discharge head MRI scans, neurological function assessments, and cognitive function assessments Visit the clinic 1 year for checkups and tests

Вмешательства

• Процедура Flow diverter
  Flow diverter (FD, preferentially a Lattice stent) placement, with adjunctive minimal coiling of the aneurysm sac as needed
• Процедура Stent-assisted coiling
  Conventional stent-assisted coil embolization was performed (with preferential use of an LVIS stent)

Первичные конечные точки

• Complete occlusion rate of middle cerebral artery bifurcation aneurysms at 1-year follow-up (assessed according to the Raymond-Roy Classification) [Срок оценки: 1 year]

Вторичные конечные точки (5)

• The rate of aneurysm recurrence at 1-year post-procedure [Срок оценки: 1 year]
• Patients' neurological outcomes at 6 months and 1 year post-procedure (mRS scores and Mini-mental state examination) [Срок оценки: 1 year]
• Patients' cognitive outcomes at 6 months and 1 year post-procedure (MMSE scores) [Срок оценки: 1 year]
• Incidence of Branch Vessel Patency and In-stent Stenosis Assessed by Digital Subtraction Angiography (DSA) [Срок оценки: 1 year]
• Total interventional procedure time (from puncture to completion of the procedure) [Срок оценки: 1 year]

Критерии участия

Критерии включения

• Unruptured wide-necked middle cerebral artery bifurcation aneurysms definitively diagnosed by CTA or DSA;
• Aneurysms requiring stent-assisted embolization with the necessity of preserving branch arteries;
• Indication for either flow diversion device or conventional stent-assisted coiling;
• Age between 18 and 70 years, inclusive;
• The subject or their legally authorized representative has signed the written informed consent form.

Критерии исключения

• Concomitant significant organ dysfunction (e.g., severe cardiac, hepatic, or renal insufficiency), chronic inflammatory disease, or malignancy;
• Pregnant or lactating women;
• Presence of significant neurological deficit (mRS score > 2);
• Presence of contraindications to flow diversion device or stent-assisted coiling (e.g., severe allergy to metallic material, contraindication to antiplatelet medication);
• Other conditions deemed unsuitable for enrollment by the investigator.

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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07372612 · 2025-LCYJ-MS-11

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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