Lumenate Observational Vasospasm Interventional Trial (LOVIT)

NCT03511040 | Unknown DMC

• 1 other identifier: PR17-006
• Study Type: interventional
• Target: 20
• Locations: 4 countries
• Sites: 5

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.

Conditions

Vasospasm, Intracranial; Subarachnoid Hemorrhage

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (1)

Lumenate Intraluminal Device

EXPERIMENTAL

Dilation of vasospastic intracranial vessels

Device: Lumenate Intraluminal Device

Interventions

Lumenate Intraluminal Device DEVICE

Dilation of vasospastic intracranial vessels

Also known as: Lumenation

Lumenate Intraluminal Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Neurvana Medical: lead

Study Sites (5)

Foundation Adolphe de Rothschild

Paris, 75019, France

NOT YET RECRUITING

Hospital Purpan

Toulouse, 31059, France

NOT YET RECRUITING

Uniklinik RWTH Aachen

Aachen, 52074, Germany

NOT YET RECRUITING

National Institute of Neurosciences

Budapest, 1145, Hungary

NOT YET RECRUITING

Karolinska Universitetssjukhuset

Stockholm, Solna, 171 76, Sweden

RECRUITING

MeSH Terms

Conditions

Vasospasm, Intracranial; Subarachnoid Hemorrhage

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Hemorrhages; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Prof. Dr. med Anastasios Mpotsaris, MD

  Uniklinik RWTH Aachen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nate Knock

CONTACT

+1-949.743.1158; nknock@NEURVANAMEDICAL.COM

Tom Fogarty

CONTACT

+1-949.743.1158; tfogarty@NEURVANAMEDICAL.COM

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, multi-center, open-label, single-arm trial

Study Record Dates

• First Submitted: April 10, 2018
• First Posted: April 27, 2018
• Study Start: March 14, 2018
• Primary Completion: October 30, 2018
• Study Completion: December 30, 2018
• Last Updated: April 27, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1); FR (2); DE (1); HU (1)