Clinical trial NCT01541254: Feasibility Study of the LVIS™ (Low-profile Visualized Intraluminal Support)Device
Official title: A Feasibility Study of the MicroVention,Inc.(LVIS™) Neurovascular Self-Expanding Retrievable Stent System in the Treatment of Wide-Necked Intracranial Artery Aneurysms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Intracranial Aneurysms
Keywords: intracranial aneurysm
wide-neck
saccular
endovascular treatment
coil embolization
stent
bare platinum
Lead sponsor: Microvention-Terumo, Inc.
Sponsor class: INDUSTRY
First posted: 2012-02-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Probable Benefit Measures as Successful Aneurysm Treatment With the LVIS™ Device, as Measured by Aneurysm Angiographic Occlusion of ≥ 90% at 6 Months (± 4 Weeks)
timeFrame: 6 months ± 4 weeks
measure: Safety Measures as Any Major Stroke or Death Within 30 Days, or Major Ipsi-lateral Stroke or Neurological Death Within 6 Months
timeFrame: 30 days-6 months
Secondary outcomes:
measure: Parent Artery Patency Measured Angiographically at 6 Months
timeFrame: 6 months
measure: Successful Delivery of the LVIS™ Device Measures by Technical Success
timeFrame: 24 hours
measure: Significant Stenosis(>50%) of the Treated Artery at 6 Months
timeFrame: 6 months
measure: Stent Migration at 6 Months
timeFrame: 6 months
measure: Device and Procedure Related Serious Adverse Events
timeFrame: Day 1-6months(± 4 months)
measure: Unplanned Embolization Coiling Within 6 Months
timeFrame: Day 1-6 months
Other outcomes:
Locations:
city: Albany
country: United States
facility: Albany Medical College
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Medical Center
state: New York
city: Philadelphia
country: United States
facility: Thomas Jefferson Hospital
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Dallas
country: United States
facility: UT Southwestern
state: Texas
city: Houston
country: United States
facility: Methodist Hospital
state: Texas
Study officials:
affiliation: Stony Brook University Medical Center
name: David Fiorella, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.