Pivotal Study:
Pivotal Study of the LVIS™ (Low Profile Visualized Intraluminal Support)
LVIS™ Coil Assist Stent
"The LVIS™ stent system allows safe and highly effective coil embolization of WNAs."
- Patients
153
- Country
US
- Clinical Centers
21
- 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%
LINK TO STUDY PAGE ClinicalTrials.gov ID NCT01793792
Please refer to IFU for the full list of risks, contraindications, warnings, and precautions:
Explore more studies
LEPI Study: Safety and Efficacy of the LVIS™ and LVIS™ Jr Devices in the Endovascular Treatment of Intracranial Aneurysms
LVIS™ Coil Assist Stent
Request more information
The information you provide through this form is necessary to respond to your request and may be shared with the relevant Terumo Neuro group entity or entities responsible for handling it. For more information on how we process your personal data and on your rights, please refer to our privacy policy.