Vasospasm, IntracranialLOVITNCT03511040
Lumenate Observational Vasospasm Interventional Trial (LOVIT)
A study testing Lumenate Intraluminal Device in people with Vasospasm, Intracranial and Subarachnoid Hemorrhage, run by Neurvana Medical at 5 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vasospasm, Intracranial, Subarachnoid Hemorrhage
- What is being tested?
- Lumenate Intraluminal Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 5 sitesin 4 countries
- Study dates
- 14 Mar 2018to 30 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
5 sites in 4 countries.
5 sites in 4 countries
France2 sites, 2 recruiting
- Not yet recruiting
Foundation Adolphe de Rothschild
Paris, 75019
Prof. Michel Piotin, MD, +33 148036829, michel.piotin@me.com
- Not yet recruiting
Hospital Purpan
Toulouse, 31059
Prof. Christophe Cognard, MD, +33 561772339, cognard.c@chu-toulouse.fr
Germany1 site, 1 recruiting
- Not yet recruiting
Uniklinik RWTH Aachen
Aachen, 52074
Prof. Dr. med Anastasios Mpotsaris, MD, +49 (0)241 8088346, ampotsaris@ukaachen.de
Hungary1 site, 1 recruiting
- Not yet recruiting
National Institute of Neurosciences
Budapest, 1145
Dr. Istvan Szikora, MD, +36 1 251 2999, h13424szi@ella.hu
Sweden1 site, 1 recruiting
- Recruiting
Karolinska Universitetssjukhuset
Stockholm, Solna, 171 76
Dr. Tommy Andersson, MD, +46 8 5177 4037, tommy.andersson@sll.se
Dr. Michael Soderman, MD, +46 8 5177 3168, michael.soderman@sll.se
About this study
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.
Read the 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.
- Conditions
- Vasospasm, Intracranial, Subarachnoid Hemorrhage
- Being tested
- Lumenate Intraluminal Device
- Medical subject headings
- Vasospasm, Intracranial, Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumenate Intraluminal DeviceDevice
Also called Lumenation
Dilation of vasospastic intracranial vessels
| Study group | Role | What they receive |
|---|---|---|
| Lumenate Intraluminal Device | Experimental | Dilation of vasospastic intracranial vessels Receives: Device: Lumenate Intraluminal Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Acute - immediate post-procedure
Secondary outcomes (2)
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
Measured: 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
Measured: 30±5 days post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2018
- Study start14 Mar 2018
- Primary completion30 Oct 2018 (estimated)
- Study completion30 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vasospasm, IntracranialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, multi-center, open-label, single-arm trial
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neurvana Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Prof. Dr. med Anastasios Mpotsaris, MD, Principal investigator, Uniklinik RWTH Aachen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03511040
- Sponsor's protocol ID
- PR17-006
- Acronym
- LOVIT
- Status last verified
- Apr 2018
- First submitted
- 10 Apr 2018
- Last updated
- 27 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lumenate Observational Vasospasm Interventional Trial (LOVIT)
- ClinicalTrials.gov ID
- NCT03511040
- Acronym / sponsor ID
- LOVIT / PR17-006
- Conditions
- Vasospasm, Intracranial, Subarachnoid Hemorrhage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Neurvana MedicalIndustry (pharma, biotech, devices)
- Study start
- 14 Mar 2018 (actual)
- Primary completion
- 30 Oct 2018 (estimated)
- Study completion
- 30 Dec 2018 (estimated)
- First posted
- 27 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, multi-center, open-label, single-arm trial
| Arm | Type | Receives |
|---|---|---|
| Lumenate Intraluminal Device | Experimental | Device: Lumenate Intraluminal DeviceDilation of vasospastic intracranial vessels |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lumenate Intraluminal DeviceAlso: LumenationDilation of vasospastic intracranial vessels | Device | Lumenate Intraluminal Device |
Primary outcome
Vasospasm treatment freedom from complication (Primary Safety Endpoint)
Time frame: 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.
2 secondary outcomes
Vessel caliber change post procedure (Secondary Effectiveness Endpoint)
Time frame: Acute - immediate post-procedure
Freedom from device-related SAEs at 30 days (Secondary Descriptive Endpoint)
Time frame: 30±5 days post-procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof. Dr. med Anastasios Mpotsaris, MD principal investigator
Uniklinik RWTH Aachen
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lumenate Intraluminal Device in people with Vasospasm, Intracranial and Subarachnoid Hemorrhage, run by Neurvana Medical at 5 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France, Germany, Hungary, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nate Knock (+1-949.743.1158 ext. 707, nknock@NEURVANAMEDICAL.COM), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vasospasm treatment freedom from complication (Primary Safety Endpoint) (time frame: Acute - immediate post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2018.