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

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

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.

Study Overview

• Status: Completed
• Conditions: Intracranial Aneurysms
• Intervention / Treatment: Device: Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.)

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • New York
    • Albany, New York, United States, 12208
      • Albany Medical College
    • Stony Brook, New York, United States, 11794
      • Stony Brook University Medical Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson Hospital
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • Texas
    • Dallas, Texas, United States, 75390
      • UT Southwestern
    • Houston, Texas, United States, 77030
      • Methodist Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Subject whose age is between 18 and 80 years old
• Subject with unruptured wide neck, saccular,intracranial aneurysm, < 20mm maximum diameter in any plane ( wide neck defined as neck width ≥ 4mm or dome to-neck ratio < 2).
• Subject's aneurysm arises from a parent vessel with a diameter of ≥ 2.5m and ≤ 4.5mm.
• Subject or his/her legally authorized representative understands the nature of the procedure and provides signed informed consent form.
• Subject is willing to return to the investigational site for the 30- day and 6-month follow-up evaluations

Exclusion Criteria:

• Subject who presents with ruptured aneurysm, unless rupture occured 30 days or more prior to screening.
• Subject who presents with an intracranial mass or currently undergoing radiation therapy for carcinoma of the head or neck region.
• Subject with an International Normalized Ratio (INR)≥ 1.5
• Subject with serum creatinine level >2mg/dl at time of enrollment
• Subject with known allergies to nickel-titanium metal
• Subject with known allergies to aspirin, heparin, ticlopidine, or clopidogrel
• Subject with a life threatening allergy to contrast(unless treatment for allergy is tolerated)
• Subject who has a known cardiac disorder, likely to be associated with cardioembolic symptoms such as atrial fibrillation
• Subject with any condition which in the opinion of the treating physician would place the subject at a high risk of embolic stroke
• Subject who is currently participating in another clinical research study
• Subject who has had a previous intracranial stenting procedure associated with the target aneurysm
• Subject who is unable to complete the required follow-up
• Subject who is pregnant or breastfeeding
• Subject who has participated in a drug study within the last 30 days

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Single Arm; Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.)	Device: Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.); Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.); Other Names: Low-profile Vizualized Intraluminal Support Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Probable Benefit Measures as Successful Aneurysm Treatment With the LVIS™ Device, as Measured by Aneurysm Angiographic Occlusion of ≥ 90% at 6 Months (± 4 Weeks)	Imaging from each subject to be reviewed by an independent core lab who will be comparing with baseline and post procedure images.	6 months ± 4 weeks
Safety Measures as Any Major Stroke or Death Within 30 Days, or Major Ipsi-lateral Stroke or Neurological Death Within 6 Months	A major stroke is defined as a new neurological event that persists for >24 hours and results in a ≥ 4 point increase in the National Institutes of Health Stroke Scale (NIHSS) score compared to baseline or compared to any subsequent lower score.	30 days-6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parent Artery Patency Measured Angiographically at 6 Months	To be assessed by Independent Core Lab.	6 months
Successful Delivery of the LVIS™ Device Measures by Technical Success	Technical success being defined as: access to the lesion, successful deployment of the LVIS™ device.	24 hours
Significant Stenosis(>50%) of the Treated Artery at 6 Months	Parent Artery will be measured baseline and compared at 6 months post procedure per review by the Independent Core Lab.	6 months
Stent Migration at 6 Months	Angiographic images will be comparing post procedure sent position to 6 months	6 months
Device and Procedure Related Serious Adverse Events	All Serious Adverse events will be reported per protocol	Day 1-6months(± 4 months)
Unplanned Embolization Coiling Within 6 Months	If the target lesion(aneurysm)treated needed further embolization within 6 months of initial treatment(detected during follow up or unscheduled visit ),data will be recorded and analyzed.	Day 1-6 months

Collaborators and Investigators

• Sponsor: Microvention-Terumo, Inc.
• Investigators: Principal Investigator: David Fiorella, M.D., Ph.D., Stony Brook University Medical Center

Publications and helpful links

General Publications

• Fiorella D, Arthur A, Boulos A, Diaz O, Jabbour P, Pride L, Turk AS, Woo HH, Derdeyn C, Millar J, Clifton A. Final results of the US humanitarian device exemption study of the low-profile visualized intraluminal support (LVIS) device. J Neurointerv Surg. 2016 Sep;8(9):894-7. doi: 10.1136/neurintsurg-2015-011937. Epub 2015 Sep 21.

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: February 15, 2012
• First Submitted That Met QC Criteria: February 23, 2012
• First Posted (Estimated): February 29, 2012

Study Record Updates

• Last Update Posted (Actual): July 1, 2025
• Last Update Submitted That Met QC Criteria: June 13, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: endovascular treatment; stent; intracranial aneurysm; coil embolization; bare platinum; wide-neck; saccular
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: G110014

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes