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

Phase 2

Completed

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

Brief 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Single Arm	Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.)	Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.)

Primary Outcome Measures

Name	Time	Method
Probable Benefit Measures as Successful Aneurysm Treatment With the LVIS™ Device, as Measured by Aneurysm Angiographic Occlusion of ≥ 90% at 6 Months (± 4 Weeks)	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.
Safety Measures as Any Major Stroke or Death Within 30 Days, or Major Ipsi-lateral Stroke or Neurological Death Within 6 Months	30 days-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.

Secondary Outcome Measures

Name	Time	Method
Significant Stenosis(>50%) of the Treated Artery at 6 Months	6 months	Parent Artery will be measured baseline and compared at 6 months post procedure per review by the Independent Core Lab.
Parent Artery Patency Measured Angiographically at 6 Months	6 months	To be assessed by Independent Core Lab.
Successful Delivery of the LVIS™ Device Measures by Technical Success	24 hours	Technical success being defined as: access to the lesion, successful deployment of the LVIS™ device.
Stent Migration at 6 Months	6 months	Angiographic images will be comparing post procedure sent position to 6 months
Device and Procedure Related Serious Adverse Events	Day 1-6months(± 4 months)	All Serious Adverse events will be reported per protocol
Unplanned Embolization Coiling Within 6 Months	Day 1-6 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.

Locations (6): Medical University of South Carolina
🇺🇸
Charleston, South Carolina, United States
Albany Medical College
🇺🇸
Albany, New York, United States
Stony Brook University Medical Center
🇺🇸
Stony Brook, New York, United States
UT Southwestern
🇺🇸
Dallas, Texas, United States
Thomas Jefferson Hospital
🇺🇸
Philadelphia, Pennsylvania, United States
Methodist Hospital
🇺🇸
Houston, Texas, United States