Pipeline Embolization for Intracranial Aneurysms

Официальное название

Pipeline Embolization Device for Intracranial Aneurysm (PEDIA): a Prospective, Multicenter Cohort Focus on Safety, Efficacy, and Haemodynamics

Обзор

This study collected the clinical, laboratory, and imaging data from patients with intracranial aneurysms, who underwent Pipeline implantation. The purpose of this study is to observe the safety, effcacy, and haemodynamics after Pipeline embolization.

Подробное описание

This study collected the clinical, laboratory, and imaging data from patients with intracranial aneurysms, who underwent Pipeline implantation. The purpose of this study is to observe the safety, effcacy, and haemodynamics after Pipeline embolization. The primary outcomes were aneurysmal occlusion status, incidence of in-stent stenosis, and functional prognosis. The secondary outcomes were hemodynamic changes before and after stent implantation.

Вмешательства

• Устройство Pipeline embolization device with or without shield technique
  The patients undenwent Pipeline embolization device implantation with or without shield technique due to market availability, choice and preferences of the surgeon.

Первичные конечные точки

• The occlusion rate of the aneurysm [Срок оценки: 1 years]

Вторичные конечные точки (2)

• in-stent stenosis [Срок оценки: 1 years]
• perioperative complications [Срок оценки: 1 months]

Критерии участия

Критерии включения

• Aged 22 to 75 years old, male or non-pregnant female;
• UIA was diagnosed by CTA, MRA, or DSA;
• The size of aneurysms is between 3 to 25mm;
• Understands the nature of the procedure and provision of written informed consent;
• Indications for FD implantation with or without adjunctive coiling;
• Is willing to return to the investigational site for follow-up according to our protocol.

Критерии исключения

• With contraindications to flow-diversion treatment or known allergy to cobalt-chromium alloy or contrast medium;
• Pregnancy or lactation;
• Coexist with other vascular lesions (coronary artery disease, abdominal aortic aneurysm, severe intracranial artery stenosis, arteriovenous malformation, dural arteriovenous fistula, Moyamoya disease, etc.);
• Parent vessel with a diameter <2.0 mm or ≥5.0 mm.;
• Unwilling to be followed up or likely to have poor treatment compliance;
• Life expectancy less than 3 years;
• Inability to receive anti-platelet or anticoagulant medication;
• Severe neurological deficit that renders the patient unable to live independently (modified Rankin score ≥4);
• Enrollment in another trial or other situations that the researcher deems unsuitable for inclusion in the study.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Zhujiang hospital — Гуанчжоу

Публикации

• Huang C, Zhu Y, Feng X, Tong X, Wen Z, Lin J, Huang M, Yuan H, Dai L, Chen W, Hu Y, Bi Y, Deng X, Xie Z, Shang G, Luo Y, Zhao Y, Peng C, Huang C, Su S, Zhang X, Li X, Guo Z, Liu A, Duan C. Stent match of pipeline embolization device: prediction of incomplete occlusion and in-stent stenosis by actual stent size after implantation. Neurosurg Rev. 2025 May 30;48(1):462. doi: 10.1007/s10143-025-03625- PMID 40442402
• Huang J, Huang Y, Feng X, Huang C, Huang M, Wen Z, Xu A, Ge R, Yuan H, Shi H, Ma G, Li C, Lin J, Yi R, Hu Y, Jin Y, Liang S, Bi Y, Su S, Zhang X, Li X, Duan C. Predictive value of the systemic immune-inflammation index for periprocedural complications in flow diverter treatment for patients with intracranial aneurysms. Neurosurg Rev. 2024 Oct 22;47(1):809. doi: 10.1007/s10143-024-03053-0. PMID 39436476

Идентификаторы

NCT: NCT06446778 · LC2024ZD027

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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