Lumenate Observational Vasospasm Interventional Trial (LOVIT)

Subarachnoid Hemorrhage Clinical Trial

— LOVIT  

Official title:

Lumenate Observational Vasospasm Interventional Trial (LOVIT)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03511040
• Other study ID #: PR17-006
• Status: Recruiting
• Phase: N/A
• First received: April 10, 2018
• Last updated: April 17, 2018
• Start date: March 14, 2018
• Est. completion date: December 30, 2018

Study information

• Verified date: April 2018
• Source: Neurvana Medical
• Contact: Nate Knock
• Phone: +1-949.743.1158
• Email: nknock[@]NEURVANAMEDICAL.COM
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 30, 2018
• Est. primary completion date: October 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hemorrhage
• Subarachnoid Hemorrhage
• Vasospasm, Intracranial

Intervention

Device:
• Lumenate Intraluminal Device
Dilation of vasospastic intracranial vessels

Locations

Country	Name	City	State
France	Foundation Adolphe de Rothschild	Paris
France	Hospital Purpan	Toulouse
Germany	Uniklinik RWTH Aachen	Aachen
Hungary	National Institute of Neurosciences	Budapest
Sweden	Karolinska Universitetssjukhuset	Stockholm	Solna

Sponsors (1)

Lead Sponsor	Collaborator
Neurvana Medical

Countries where clinical trial is conducted

France,  Germany,  Hungary,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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