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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2013-06-30

Brief Summary

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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.

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Detailed Description

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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

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Intracranial Aneurysms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single Arm

Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.)

Group Type OTHER

Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.)

Intervention Type DEVICE

Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.)

Interventions

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Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.)

Intervention Type DEVICE

Other Intervention Names

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Low-profile Vizualized Intraluminal Support Device

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No