Clinical trial NCT03511040: Lumenate Observational Vasospasm Interventional Trial (LOVIT)
Official title: Lumenate Observational Vasospasm Interventional Trial (LOVIT)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vasospasm, Intracranial
Subarachnoid Hemorrhage
Lead sponsor: Neurvana Medical
Sponsor class: INDUSTRY
First posted: 2018-04-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, multi-center, open-label, single-arm trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Vasospasm treatment freedom from complication (Primary Safety Endpoint)
timeFrame: Acute - immediate post-procedure
Secondary outcomes:
measure: Vessel caliber change post procedure (Secondary Effectiveness Endpoint)
timeFrame: Acute - immediate post-procedure
measure: Freedom from device-related SAEs at 30 days (Secondary Descriptive Endpoint)
timeFrame: 30±5 days post-procedure
Other outcomes:
Locations:
city: Paris
country: France
facility: Foundation Adolphe de Rothschild
city: Toulouse
country: France
facility: Hospital Purpan
city: Aachen
country: Germany
facility: Uniklinik RWTH Aachen
city: Budapest
country: Hungary
facility: National Institute of Neurosciences
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhuset
state: Solna
Study officials:
affiliation: Uniklinik RWTH Aachen
name: Prof. Dr. med Anastasios Mpotsaris, MD
role: PRINCIPAL_INVESTIGATOR
References: