LVIS™ Coil Assist Stent

Pivotal Study: Pivotal Study of the LVIS™ (Low Profile Visualized Intraluminal Support)

"The LVIS™ stent system allows safe and highly effective coil embolization of WNAs."

Patients

153

Country

Clinical Centers

Design

Single arm prospective

Scope

Patient 18-75 y.o., with an unruptured or ruptured (>30 days) wide neck (neck ≥4 mm or dome:neck ratio ≤2), saccular, intracranial aneurysm, ≥4 mm and <20 mm maximum diameter.

Purpose

IDE study to determine the safety and effectiveness of the LVIS™ device to treat wide neck aneurysms located in the anterior and posterior intracranial circulations .
Data from this study were used to support a US regulatory submission for premarket approval.

Evaluate safety and effectiveness of LVIS™ and LVIS™ Jr in support of an application for Food and Drug Administration approval in the USA.

Endpoints

Effectiveness: Composite Success defined as complete (100%) aneurysm angiographic occlusion without retreatment and without significant (≥50%) stenosis of the treated artery at 12 months (assessed by Corelab)

Safety: Rate of stroke or death within 30 days, or ipsilateral stroke or neurologic death with 12 months

Efficacy results

Primary effectiveness endpoint result at 12 months: 70.6%

Complete occlusion at 12 months: 79.1%
≥95% occlusion at 12 months: 92.1%
≥90% occlusion at 12 months: 95%

Safety results

Rate of stroke or death within 30 days, or ipsilateral stroke or neurologic death with 12 months: 5.2%

Study publications

The safety and effectiveness of the LVIS stent system for the treatment of wide-necked cerebral aneurysms: final results of the pivotal US LVIS trial – Fiorella D, et al. J Neurointerv Surg. 2019; 11(4); 357-361.

LINK TO STUDY PAGE ClinicalTrials.gov ID NCT01793792

Please refer to IFU for the full list of risks, contraindications, warnings, and precautions.

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