Lumenate Observational Vasospasm Interventional Trial (LOVIT)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Lumenate Observational Vasospasm Interventional Trial (LOVIT)

Conditions
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Vasospasm, Intracranial, Subarachnoid Hemorrhage

Intervention / Treatment
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* Device: Lumenate Intraluminal Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective, multi-center, open-label, single-arm trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lumenate Intraluminal Device<br>Dilation of vasospastic intracranial vessels | Device: Lumenate Intraluminal Device<br>* Dilation of vasospastic intracranial vessels<br>* Other names: Lumenation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vasospasm treatment freedom from complication (Primary Safety Endpoint) | 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. | Acute - immediate post-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vessel caliber change post procedure (Secondary Effectiveness Endpoint) | The study's primary effectiveness endpoint is an improvement in the caliber of the treated vasospastic vessel by at least 1 point on the 4-point angiographic scale | Acute - immediate post-procedure | 
| Freedom from device-related SAEs at 30 days (Secondary Descriptive Endpoint) | Any device-related serious adverse events at 30±5 days post-treatment | 30±5 days post-procedure |