Lumenate Observational Vasospasm Interventional Trial (LOVIT)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 10
- 主要终点
- Vasospasm treatment freedom from complication (Primary Safety Endpoint)
研究概览
简要总结
The LOVIT study is a European prospective, multi-center, open-label, single-arm feasibility trial designed to determine the safety and angiographic effectiveness through 30 days post treatment with Lumenate Intraluminal Device in the treatment of symptomatic vasospasm.
详细描述
The Neurvana Lumenate Intraluminal Device is delivered via a percutaneous endovascular approach to the target segment for mechanical assistance and the treatment of vasospasm.
The LOVIT study is a European prospective, multi-center, open-label, single-arm feasibility trial designed to determine the safety and angiographic effectiveness through 30 days post treatment with Lumenate Intraluminal Device in the treatment of symptomatic vasospasm. The primary objective of the study is to support the CE-mark vasospasm label claim for the Lumenate Device. The study will be enrolled at up to 8 European sites with study subjects being followed for 90 days post-treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Subject has the necessary mental capacity to participate and is willing and able to comply with protocol requirements
- •Patient has suffered SAH from a ruptured intracranial aneurysm
- •Has mWFNS ≤3 upon admission to the treating hospital or mWFNS ≤3 after insertion of an endoventricular drain (EVD) for acute hydrocephalus secondary to SAH.
- •Subject has provided written informed consent using the IRB/Ethics committee-approved consent form and are willing to comply with the study protocol and planned follow-ups.
- •Patients that develop symptoms of cerebral vasospasm, as determined by the physician, and/or have diagnostic (e.g. TCD) or radiological evidence of moderate/severe vasospasm.
排除标准
- •Patients that have angiographically confirmed (CTA/MRA) vasospasm at admission to the treating hospital
- •Subjects who require surgical treatment of culprit aneurysm.
- •Endovascular treatment of culprit aneurysm resulting in severe procedural complication (e.g., vessel rupture, embolization or other complication).
- •Placement of intraluminal stent or flow diverter is used to treat culprit aneurysm.
- •Intraluminal stent or flow diverter placed in the 6 months prior to culprit aneurysm rupture.
- •Treated with Intra Arterial vasodilators prior to Lumenate procedure
- •Receiving Anti-coagulant with half-life longer than 24 hours, or Dual antiplatelet therapy (DAPT) including P2Y12 inhibition
- •Woman of child-bearing potential who cannot provide a negative pregnancy test.
- •Patients with vasculitis or connective tissue disorders that put them at risk for vasculitis.
- •Known use of cocaine or methamphetamine within the last month.
- •Any comorbid disease or medical condition with a life expectancy ≤3 months.
- •Known allergy or contraindication to aspirin, heparin, local or general anesthesia
- •Known history of life threatening allergy to contrast dye
- •Serum creatinine ≥2.5 mg/dL
- •Enrollment in another trial involving an investigational product
- •Physician discretion that the patient may not benefit from treatment with Lumenate - reason for exclusion should be documented.
结局指标
主要结局
Vasospasm treatment freedom from complication (Primary Safety Endpoint)
时间窗: Acute - immediate post-procedure
No occurrence of device-related procedural complications as assessed by the post treatment angiogram. Catheter angiography will be used to determine the absence/presence of vessel wall disruption (e.g., dissection, perforation) or presence of thrombus within the target vessel.
次要结局
- Vessel caliber change post procedure (Secondary Effectiveness Endpoint)(Acute - immediate post-procedure)
- Freedom from device-related SAEs at 30 days (Secondary Descriptive Endpoint)(30±5 days post-procedure)