NCT03511040

Lumenate Observational Vasospasm Interventional Trial (LOVIT)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Neurvana Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Vasospasm, Intracranial
• Subarachnoid Hemorrhage

Interventions

Type	Name	Description
DEVICE	Lumenate Intraluminal Device	Dilation of vasospastic intracranial vessels

Timeline

• Start date: 2018-03-14
• Primary completion: 2018-10-30
• Completion: 2018-12-30
• First posted: 2018-04-27
• Last updated: 2018-04-27

Locations

5 sites across 4 countries: France, Germany, Hungary, Sweden