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

MicroVention

Status and phase

Completed

Phase 3

Phase 2

Conditions

Intracranial Aneurysms

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT01541254

G110014

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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