NCT01748903Unknown不适用
TARGET Intracranial Aneurysm Coiling Registry: A Prospective Clinical Efficacy and Safety Study of Stryker Target® 360°, Target® Helical, and 2nd Generation Target® Nano Coils
Mercy Health Ohio9 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2013年2月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 9
- 主要终点
- Packing Density
研究概览
简要总结
The purpose of this prospective registry is to collect real world, post-marketing data on the use of Stryker Target® 360,Target® 2D, and 2nd generation Target® Nano coils for the embolization of ruptured or unruptured intracranial saccular aneurysms. Up to 300 patients (150 in the TARGET 360°/Helical arm and 150 in the New NANO arm) presenting with intracranial aneurysms suitable for coil embolization will be enrolled at up to 20 sites. A post hoc analysis comparing Target® 360° and Target® 2D coil technical and clinical endpoints will be performed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is 18 years or older.
- •Patient has a documented, previously untreated, saccular intracranial aneurysm, unruptured or ruptured, suitable for embolization with coils.
- •(NEW NANO arm ONLY) Target aneurysm is ≤7mm.
- •Patient has a Hunt and Hess Score of 3 or less.
- •Patient has a premorbid mRS of 3 or less.
- •Patient or patient's legally authorized representative has provided written informed consent.
- •Patient is willing to and can comply with study follow-up requirements.
排除标准
- •Patient is < 18 years old.
- •Dissecting aneurysm.
- •Patients with intracranial aneurysms (other than the target aneurysm) that will require treatment during the study period (enrollment through follow-up).
- •Patients in whom the target aneurysm will be treated with coils other than Stryker Target® 360°, Target® Helical coils, and 2nd generation Target® Nano Coils.
- •(NEW NANO Arm ONLY) Patients in whom the target aneurysm was treated with a total coil length comprised of <25% Stryker Target® 2nd generation Nano Coils.
- •Target aneurysm is fusiform.
- •Patients in which the target aneurysm cannot be coiled in one procedure (i.e. staged procedure)
结局指标
主要结局
Packing Density
时间窗: At immediate post-procedure (Day 1)
Packing density will be calculated based on aneurysm volume and amount of coil used during the embolization procedure.
次要结局
- Aneurysm Re-access Rate(At end of study procedure (Day 1))
- Modified Rankin Score(At baseline (Day 1) and hospital discharge (Day 3) and 3-9 month follow-up)
- Treatment-related Morbidity and Mortality(from study procedure (Day 1) to 3-9 month follow-up)
- Occlusion Rate(At immediate post-procedure (Day 1) and 3-9 month follow-up)
- Time of Fluoroscopic Exposure(At immediate post-procedure (Day 1))
- Device-related serious adverse events(From the study procedure (Day 1) until 3-9 month follow up)
- Length of hospital stay(At hospital discharge (Day 3))
- Overall Procedure Time(At Immediate post-procedure (Day 1))
- Aneurysm Recurrence(3-9 month follow-up)
- Aneurysm Re-treatment Rate(3-9 month follow-up)
- Aneurysm Bleed and Re-bleed Rate(3-9 month follow-up)
- Technical and clinical endpoints of Target 360° and 2D coils(3-9 month follow-up)
研究者
Dr. Osama O. Zaidat
Medical Director, Neuroscience and Stroke Programs
Mercy Health Ohio
研究点 (9)
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