Subarachnoid Hemorrhage, Vasospasm, Intracranial
Conditions
Brief summary
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
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.
Interventions
DEVICELumenate Intraluminal Device
Dilation of vasospastic intracranial vessels
Sponsors
Neurvana Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, multi-center, open-label, single-arm trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 2. Subject has the necessary mental capacity to participate and is willing and able to comply with protocol requirements 3. Patient has suffered SAH from a ruptured intracranial aneurysm 4. 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. 5. 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. 6. 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
1. Patients that have angiographically confirmed (CTA/MRA) vasospasm at admission to the treating hospital 2. Subjects who require surgical treatment of culprit aneurysm. 3. Endovascular treatment of culprit aneurysm resulting in severe procedural complication (e.g., vessel rupture, embolization or other complication). 4. Placement of intraluminal stent or flow diverter is used to treat culprit aneurysm. 5. Intraluminal stent or flow diverter placed in the 6 months prior to culprit aneurysm rupture. 6. Treated with Intra Arterial vasodilators prior to Lumenate procedure 7. Receiving Anti-coagulant with half-life longer than 24 hours, or Dual antiplatelet therapy (DAPT) including P2Y12 inhibition 8. Woman of child-bearing potential who cannot provide a negative pregnancy test. 9. Patients with vasculitis or connective tissue disorders that put them at risk for vasculitis. 10. Known use of cocaine or methamphetamine within the last month. 11. Any comorbid disease or medical condition with a life expectancy ≤3 months. 12. Known allergy or contraindication to aspirin, heparin, local or general anesthesia 13. Known history of life threatening allergy to contrast dye 14. Serum creatinine ≥2.5 mg/dL 15. Enrollment in another trial involving an investigational product 16. Physician discretion that the patient may not benefit from treatment with Lumenate - reason for exclusion should be documented.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vasospasm treatment freedom from complication (Primary Safety Endpoint) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vessel caliber change post procedure (Secondary Effectiveness Endpoint) | Acute - immediate post-procedure | 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 |
| Freedom from device-related SAEs at 30 days (Secondary Descriptive Endpoint) | 30±5 days post-procedure | Any device-related serious adverse events at 30±5 days post-treatment |
Countries
France, Germany, Hungary, Sweden
Contacts
Primary ContactNate Knock
Backup ContactTom Fogarty
Outcome results
None listed