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 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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Dilation of vasospastic intracranial vessels
Foundation Adolphe de Rothschild
Paris, France
NOT_YET_RECRUITINGHospital Purpan
Toulouse, France
NOT_YET_RECRUITINGUniklinik RWTH Aachen
Aachen, Germany
NOT_YET_RECRUITINGVasospasm 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.
Time frame: Acute - immediate post-procedure
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
Time frame: 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
Time frame: 30±5 days post-procedure
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
National Institute of Neurosciences
Budapest, Hungary
NOT_YET_RECRUITINGKarolinska Universitetssjukhuset
Stockholm, Solna, Sweden
RECRUITING