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

Purpose

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.

Condition	Intervention	Phase
Intracranial Aneurysms	Device: LVIS ™ and LVIS™Jr. MicroVention	Phase 2 Phase 3

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Aneurysms Brain Aneurysm

U.S. FDA Resources

Further study details as provided by Microvention-Terumo, Inc.:

Primary Outcome Measures:

Probable benefit measures as successful aneurysm treatment with the LVIS™ device, as measured by aneurysm angiographic occlusion of ≥ 90% at 6 months (± 4 weeks) [ Time Frame: 6 months ± 4 weeks ] [ Designated as safety issue: No ]
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 [ Time Frame: 30 days-6 months ] [ Designated as safety issue: Yes ]
A major stroke is defined as a new neurological event that persists for >24 hours and results in a ≥ 4 point increase in the NIHSS score compared to baseline or compared to any subsequent lower score.

Secondary Outcome Measures:

Parent artery patency measured angiographically at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
To be assessed by Independent Core Lab.
Successful delivery of the LVIS™ device measures by technical success [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Technical success being defined as: access to the lesion, successful deployment of the LVIS™ device.
Significant stenosis(>50%) of the treated artery at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Parent Artery will be measured baseline and compared at 6 months post procedure per review by the Independent Core Lab.
Stent migration at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Angiographic images will be comparing post procedure sent position to 6 months
Device and procedure related Serious Adverse Events [ Time Frame: Day 1-6months(± 4 months) ] [ Designated as safety issue: Yes ]
All Serious Adverse events will be reported per protocol
Unplanned embolization coiling within 6 months [ Time Frame: Day 1-6 months ] [ Designated as safety issue: No ]
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.

Estimated Enrollment:	30
Study Start Date:	March 2012
Estimated Study Completion Date:	June 2013
Primary Completion Date:	November 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Single Arm Device: LVIS ™ and LVIS™Jr. MicroVention	Device: LVIS ™ and LVIS™Jr. MicroVention (LVIS ™ and LVIS ™ Jr.)MicroVention Other Names: LVIS™ and LVIS™ Jr. MicroVention Low-profile Vizualized Intraluminal Support Device

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

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 AFIB (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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01541254

Locations

United States, New York
Albany Medical College
Albany, New York, United States, 12208
Stony Brook University Medical Center
Stony Brook, New York, United States, 11794
United States, Pennsylvania
Thomas Jefferson Hospital
Philadelphia, Pennsylvania, United States, 19107
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Texas
UT Southwestern
Dallas, Texas, United States, 75390
Methodist Hospital
Houston, Texas, United States, 77030

Sponsors and Collaborators

Microvention-Terumo, Inc.

Investigators

Principal Investigator:

David Fiorella, M.D., Ph.D.

Stony Brook University Medical Center

More Information

No publications provided

Responsible Party:	Microvention-Terumo, Inc.
ClinicalTrials.gov Identifier:	NCT01541254 History of Changes
Other Study ID Numbers:	G110014
Study First Received:	February 15, 2012
Last Updated:	February 14, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Microvention-Terumo, Inc.:

intracranial aneurysm
wide-neck
saccular
endovascular treatment

coil embolization
stent
bare platinum

Additional relevant MeSH terms:

Aneurysm
Intracranial Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases

Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 16, 2013