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Pivotal Study of the LVIS (Low Profile Visualized Intraluminal Support) (LVIS)

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ClinicalTrials.gov Identifier: NCT01793792
Recruitment Status : Completed
First Posted : February 18, 2013
Results First Posted : November 27, 2019
Last Update Posted : November 27, 2019
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 efficacy of the Low Profile Visualized Intraluminal Support(LVIS™ and LVIS™ Jr.)devices from MicroVention, Inc. when used to facilitate endovascular coiling of wide-necked intracranial aneurysms with coils.

Condition or disease Intervention/treatment Phase
Intracranial Aneurysms Device: LVIS™ and LVIS™ Jr Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 153 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Low Profile Visualized Intraluminal Support device
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pivotal Study of the Microvention, Inc Neurovascular Self-Expanding Retrievable Stent System LVIS
Study Start Date : July 2013
Actual Primary Completion Date : November 2015
Actual Study Completion Date : January 2016

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Arms and Interventions
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Arm Intervention/treatment
Device: LVIS

The LVIS Device is intended for use with embolization coils for the treatment of wide neck, intracranial aneurysms.

Device: LVIS™ and LVIS™ Jr. MicroVention Low-profile Visualized Intraluminal Support Device

 Device: LVIS™ and LVIS™ Jr
The LVIS Device is intended for use with embolization coils for the treatment of wide neck, intracranial aneurysms.
Other Name: Low Profile Visualized Intraluminal Support device


Outcome Measures
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Primary Outcome Measures :
  1. Primary Effectiveness Composite Success "Number of Participants With Primary Effectiveness Composite Success (100% Aneurysm Occlusion Without Clinically Significant In-stent Stenosis or Target Aneurysm Retreatment" [ Time Frame: 12 months ]
  2. Primary Safety Composite Rate (Disabling Stroke With mRS Score Greater Than or Equal to 3, or Neurological Death Within 12 Months [ Time Frame: 12 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject age between 18 and 75 years
  • Subject with an unruptured or ruptured(>30days since occurence), wide-necked (neck ≥4mm or dome to neck ratio <2)intracranial saccular aneurysm (<20mm maximum diameter in any plane)

Exclusion Criteria:

  • Subject with significant extra or intracranial stenosis of the parent artery (>50%) proximal to the target aneurysm.
  • Subject with any condition which in the opinion of the treating physician would place the subject at high risk of embolic stroke
  • Subject with contraindications to the use of antiplatelet agents
  • Subject who is unable to complete the required follow-up
Contacts and Locations
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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): NCT01793792


Locations
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Sponsors and Collaborators
Microvention-Terumo, Inc.
Investigators
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Principal Investigator: David Fiorella, M.D. Stony Brook University Medical Center
More Information
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Additional Information:

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

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Responsible Party: Microvention-Terumo, Inc.
ClinicalTrials.gov Identifier: NCT01793792    
Other Study ID Numbers: CL11002
G110188/S004 ( Other Identifier: FDA )
First Posted: February 18, 2013    Key Record Dates
Results First Posted: November 27, 2019
Last Update Posted: November 27, 2019
Last Verified: November 2019
Keywords provided by Microvention-Terumo, Inc.:
intracranial, saccular, aneurysms, stenting, coiling
Additional relevant MeSH terms:
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Intracranial Aneurysm
Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
 Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases