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

Completed · Phase 2/Phase 3

Conditions studied: Intracranial Aneurysms

In brief

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.

Key facts

Study ID

NCT01541254

Run by

Microvention-Terumo, Inc.

People needed

30

Starts

2012-03-01

Expected to finish

2013-06-01

Last updated by the study team

2025-07-01

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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