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

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ClinicalTrials.gov Identifier: NCT01541254
Recruitment Status : Completed
First Posted : February 29, 2012
Results First Posted : September 15, 2014
Last Update Posted : September 15, 2014
Sponsor:
Information provided by (Responsible Party):
Microvention-Terumo, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Intracranial Aneurysms Device: Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.) Phase 2 Phase 3

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : March 2012
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Single Arm
Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.)
 Device: Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.)
Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.)
Other Name: Low-profile Vizualized Intraluminal Support Device


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
    Imaging from each subject to be reviewed by an independent core lab who will be comparing with baseline and post procedure images.

  2. 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 ]
    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 :
  1. Parent Artery Patency Measured Angiographically at 6 Months [ Time Frame: 6 months ]
    To be assessed by Independent Core Lab.

  2. Successful Delivery of the LVIS™ Device Measures by Technical Success [ Time Frame: 24 hours ]
    Technical success being defined as: access to the lesion, successful deployment of the LVIS™ device.

  3. Significant Stenosis(>50%) of the Treated Artery at 6 Months [ Time Frame: 6 months ]
    Parent Artery will be measured baseline and compared at 6 months post procedure per review by the Independent Core Lab.

  4. Stent Migration at 6 Months [ Time Frame: 6 months ]
    Angiographic images will be comparing post procedure sent position to 6 months

  5. Device and Procedure Related Serious Adverse Events [ Time Frame: Day 1-6months(± 4 months) ]
    All Serious Adverse events will be reported per protocol

  6. Unplanned Embolization Coiling Within 6 Months [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Microvention-Terumo, Inc.
ClinicalTrials.gov Identifier: NCT01541254     History of Changes
Other Study ID Numbers: G110014
First Posted: February 29, 2012    Key Record Dates
Results First Posted: September 15, 2014
Last Update Posted: September 15, 2014
Last Verified: September 2014

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