NCT01541254

Feasibility Study of the LVIS™ (Low-profile Visualized Intraluminal Support)Device

A Feasibility Study of the MicroVention,Inc.(LVIS™) Neurovascular Self-Expanding Retrievable Stent System in the Treatment of Wide-Necked Intracranial Artery Aneurysms

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Microvention-Terumo, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and probable benefit of the Low-profile Visualized Intraluminal Support (LVIS™ and LVIS™ Jr.)devices from MicroVention, Inc. when used to facilitate endovascular coiling of unruptured wide-neck intracranial aneurysms with bare platinum embolization coils.

Detailed description

With the stent-assisted technique to treat wide neck intracranial aneurysms, the neurovascular stent is placed across the aneurysm neck, to act as a bridge to prevent coils from protruding into the parent artery. Stenting may allow to more safely achieve a higher packing density of coils. These effects may improve the rates of complete aneurysm occlusion and enhance the durability of the coiling treatment.The LVIS™ device manufactured by MicroVention, Inc. has a braided design which may provide superior conformability and parent artery apposition, as well as a more reliable continuous and uniform neck bridging than other neurovascular stents.

Conditions

• Intracranial Aneurysms

Interventions

Type	Name	Description
DEVICE	Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.)	Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.)

Timeline

• Start date: 2012-03-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2012-02-29
• Last updated: 2025-07-01
• Results posted: 2014-09-15

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated device study