Parent Artery Reconstruction for Small Unruptured Cerebral Aneurusms Using Flow DiverTers: a Multicenter Randomized Trial(PARAT-MT)

Обзор

A prospective, multicenter, randomized controlled clinical trial with open-label treatment and blinded endpoint assessment.

Подробное описание

The PARAT-MT is to evaluate whether small unruptured cerebral aneurusm patients treated with FD superior to those treated with conventional endovascular therapy. It is a prospective, multicenter, randomized controlled clinical trial with open-label treatment and blinded endpoint assessment trial.

Primary Outcome Endpoint A composite endpoint of major recurrence, any stroke or death at one year post-surgery.

Second Outcome Endpoint

1. All-cause mortality at 12 months post-surgery. 2. Any stroke at 12 months post-surgery. 3. Major recurrence rate at 12 months post-surgery. 4. Transient ischemic attack (TIA) occurrence rate at 12 months post-surgery. 5. Periprocedural (30-day) procedure-related complications rate. 6. Ipsilateral stroke or neurologic death at 1 month and 12 months post-surgery 7. Severe disability rate at 1 month and 12 months post-surgery (mRS \> 2). 8. Complete aneurysm occlusion rate at 12 months post-surgery (Raymond I). 9. The rate of in-stent stenosis ≥50% at 12 months post-surgery. 10. Incidence of hemorrhagic stroke at 12 months post-surgery. 11. Technical success rate. 12. Target parent artery retreatment rate at 12 months post-surgery. 13. Target aneurysm retreatment rate at 12 months post-surgery. 14. Surgical operation time. 15. Radiation dose.

Вмешательства

• Устройство Flow Diversion for Endovascular Treatment of Intracranial Aneurysms
  Flow Diversion for Endovascular Treatment of Intracranial Aneurysms
• Устройство Conventional endovascular therapy (stent-assisted coiling, balloon-assisted coiling, or coiling) for endovascular treatment of intracranial aneurysms
  Conventional endovascular therapy (stent-assisted coiling, balloon-assisted coiling, or coiling) for endovascular treatment of intracranial aneurysms

Первичные конечные точки

• Major recurrence, any stroke or death [Срок оценки: At 1 year post-surgery]

Вторичные конечные точки (12)

• All-cause mortality [Срок оценки: At 12 months post-surgery]
• Any stroke [Срок оценки: At 12 months post-surgery]
• Major recurrence [Срок оценки: At 12 months post-surgery]
• Transient ischemic attack (TIA) [Срок оценки: At 12 months post-surgery]
• Procedure-related complications [Срок оценки: Periprocedural (30 days)]
• Ipsilateral stroke or neurologic death [Срок оценки: At 1 month and 12 months post-surgery]
• Severe disability [Срок оценки: At 1 month and 12 months post-surgery]
• Complete aneurysm occlusion [Срок оценки: at 12 months post-surgery]
• The rate of in-stent stenosis ≥50% [Срок оценки: At 12 months post-surgery]
• hemorrhagic stroke [Срок оценки: at 12 months post-surgery]
• Technical success rate [Срок оценки: 24 hours after endovascular treatment]
• Target parent artery retreatment rate [Срок оценки: At 12 months post-surgery]

Критерии участия

Критерии включения

• Age 18-75 years.
• Previously unruptured saccular cerebral aneurysm arising from intradural segments of the internal carotid artery and intracranial segments of the vertebral artery.
• Measuring ≤10mm in maximum diameter
• Subjects capable of understanding the study's purpose, willing to participate, and have signed an informed consent form.

Критерии исключения

• Subjects with two or more multiple aneurysms requiring treatment within one year.
• Subjects with arteriovenous malformations or moyamoya disease.
• Subjects with ruptured, recurrent, or dissecting aneurysms.
• Subjects with symptomatic cerebral stenosis >70%;
• Subjects who have experienced a stroke (cerebral hemorrhage, cerebral infarction) within the past month.
• Clinical condition is extremely poor with a modified Rankin score of ≥3.
• Subjects planned for surgical/interventional procedures within three months.
• Subjects deemed inappropriate for interventional treatment by the investigator (e.g., no suitable vascular access, excessively tortuous vessels, difficult stent delivery, etc.).
• Subjects with severe comorbidities, unsuitable for anesthesia or endovascular surgery (e.g., major cardiac, pulmonary, hepatic, splenic, renal diseases, atrial fibrillation ,brain tumors, severe active infections, disseminated intravascular coagulation, history of severe mental illness).
• Subjects unable to tolerate antiplatelet or anticoagulant therapy.
• Subjects who has had or are likely to have a severe reaction to contrast media.
• Subjects with a history of allergy to nickel-titanium, cobalt-chromium, or platinum-tungsten alloys.
• Subjects who have participated in other drug or medical device clinical trials and have not reached the primary endpoint time limit.
• Pregnant or breastfeeding women.
• Subjects with an expected lifespan of less than 12 months.
• Subjects deemed by the investigator to have poor compliance, unable to complete the study as required.

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

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06600997 · PARAT-MT

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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