Lumenate Observational Vasospasm Interventional Trial (LOVIT) (LOVIT)

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.

Study Overview

• Status: Unknown
• Conditions: Subarachnoid Hemorrhage; Vasospasm, Intracranial
• Intervention / Treatment: Device: Lumenate Intraluminal Device

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75019
    • Not yet recruiting
    • Foundation Adolphe de Rothschild
    • Contact: Prof. Michel Piotin, MD; Phone Number: +33 148036829; Email: michel.piotin@me.com
  • Toulouse, France, 31059
    • Not yet recruiting
    • Hospital Purpan
    • Contact: Prof. Christophe Cognard, MD; Phone Number: +33 561772339; Email: cognard.c@chu-toulouse.fr
• Germany
  • Aachen, Germany, 52074
    • Not yet recruiting
    • Uniklinik RWTH Aachen
    • Contact: Prof. Dr. med Anastasios Mpotsaris, MD; Phone Number: +49 (0)241 8088346; Email: ampotsaris@ukaachen.de
• Hungary
  • Budapest, Hungary, 1145
    • Not yet recruiting
    • National Institute of Neurosciences
    • Contact: Dr. Istvan Szikora, MD; Phone Number: +36 1 251 2999; Email: h13424szi@ella.hu
• Sweden
  • Solna
    • Stockholm, Solna, Sweden, 171 76
      • Recruiting
      • Karolinska Universitetssjukhuset
      • Contact: Dr. Tommy Andersson, MD; Phone Number: +46 8 5177 4037; Email: tommy.andersson@sll.se
      • Contact: Dr. Michael Soderman, MD; Phone Number: +46 8 5177 3168; Email: michael.soderman@sll.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Lumenate Intraluminal Device; Dilation of vasospastic intracranial vessels	Device: Lumenate Intraluminal Device; Dilation of vasospastic intracranial vessels; Other Names: Lumenation

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Neurvana Medical
• Investigators: Principal Investigator: Prof. Dr. med Anastasios Mpotsaris, MD, Uniklinik RWTH Aachen

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 14, 2018
• Primary Completion (ANTICIPATED): October 30, 2018
• Study Completion (ANTICIPATED): December 30, 2018

Study Registration Dates

• First Submitted: April 10, 2018
• First Submitted That Met QC Criteria: April 17, 2018
• First Posted (ACTUAL): April 27, 2018

Study Record Updates

• Last Update Posted (ACTUAL): April 27, 2018
• Last Update Submitted That Met QC Criteria: April 17, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Hemorrhages; Hemorrhage; Subarachnoid Hemorrhage; Vasospasm, Intracranial
• Other Study ID Numbers: PR17-006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No