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Lumenate Observational Vasospasm Interventional Trial (LOVIT) (LOVIT)

Primary Purpose

Vasospasm, Intracranial, Subarachnoid Hemorrhage

Status

Unknown status

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Lumenate Intraluminal Device

About this trial

This is an interventional treatment trial for Vasospasm, Intracranial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Foundation Adolphe de Rothschild
Hospital Purpan
Uniklinik RWTH Aachen
National Institute of Neurosciences
Karolinska UniversitetssjukhusetRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lumenate Intraluminal Device

Arm Description

Dilation of vasospastic intracranial vessels

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Freedom from device-related SAEs at 30 days (Secondary Descriptive Endpoint)

Any device-related serious adverse events at 30±5 days post-treatment

Full Information

NCT ID

NCT03511040

First Posted

April 10, 2018

Last Updated

April 17, 2018

Sponsor

Neurvana Medical

1. Study Identification

Unique Protocol Identification Number

NCT03511040

Brief Title

Lumenate Observational Vasospasm Interventional Trial (LOVIT)

Acronym

LOVIT

Official Title

Lumenate Observational Vasospasm Interventional Trial (LOVIT)

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Unknown status

Study Start Date

March 14, 2018 (Actual)

Primary Completion Date

October 30, 2018 (Anticipated)

Study Completion Date

December 30, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Neurvana Medical

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vasospasm, Intracranial, Subarachnoid Hemorrhage

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Prospective, multi-center, open-label, single-arm trial

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Lumenate Intraluminal Device

Arm Type

Experimental

Arm Description

Dilation of vasospastic intracranial vessels

Intervention Type

Device

Intervention Name(s)

Lumenate Intraluminal Device

Other Intervention Name(s)

Lumenation

Intervention Description

Dilation of vasospastic intracranial vessels

Primary Outcome Measure Information:

Title

Vasospasm treatment freedom from complication (Primary Safety Endpoint)

Description

Time Frame

Acute - immediate post-procedure

Secondary Outcome Measure Information:

Title

Vessel caliber change post procedure (Secondary Effectiveness Endpoint)

Description

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

Time Frame

Acute - immediate post-procedure

Title

Freedom from device-related SAEs at 30 days (Secondary Descriptive Endpoint)

Description

Any device-related serious adverse events at 30±5 days post-treatment

Time Frame

30±5 days post-procedure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Nate Knock

Phone

+1-949.743.1158

Ext

707

nknock@NEURVANAMEDICAL.COM

First Name & Middle Initial & Last Name or Official Title & Degree

Tom Fogarty

Phone

+1-949.743.1158

tfogarty@NEURVANAMEDICAL.COM

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Prof. Dr. med Anastasios Mpotsaris, MD

Organizational Affiliation

Uniklinik RWTH Aachen

Official's Role

Principal Investigator

Facility Information:

Facility Name

Foundation Adolphe de Rothschild

City

Paris

ZIP/Postal Code

75019

Country

France

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Prof. Michel Piotin, MD

Phone

+33 148036829

michel.piotin@me.com

Facility Name

Hospital Purpan

City

Toulouse

ZIP/Postal Code

31059

Country

France

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Prof. Christophe Cognard, MD

Phone

+33 561772339

cognard.c@chu-toulouse.fr

Facility Name

Uniklinik RWTH Aachen

City

Aachen

ZIP/Postal Code

52074

Country

Germany

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Prof. Dr. med Anastasios Mpotsaris, MD

Phone

+49 (0)241 8088346

ampotsaris@ukaachen.de

Facility Name

National Institute of Neurosciences

City

Budapest

ZIP/Postal Code

1145

Country

Hungary

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Dr. Istvan Szikora, MD

Phone

+36 1 251 2999

h13424szi@ella.hu

Facility Name

Karolinska Universitetssjukhuset

City

Stockholm

State/Province

Solna

ZIP/Postal Code

171 76

Country

Sweden

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Dr. Tommy Andersson, MD

Phone

+46 8 5177 4037

tommy.andersson@sll.se

First Name & Middle Initial & Last Name & Degree

Dr. Michael Soderman, MD

Phone

+46 8 5177 3168

michael.soderman@sll.se

12. IPD Sharing Statement

Plan to Share IPD

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Lumenate Observational Vasospasm Interventional Trial (LOVIT)

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