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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Microvention-Terumo, Inc.
Sponsor:
Information provided by (Responsible Party):
Microvention-Terumo, Inc.
ClinicalTrials.gov Identifier:
NCT01793792
First received: February 14, 2013
Last updated: August 7, 2014
Last verified: August 2014
  Purpose

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 Intervention Phase
Intracranial Aneurysms
Device: LVIS™ and LVIS™ Jr
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: Pivotal Study of the Microvention, Inc Neurovascular Self-Expanding Retrievable Stent System LVIS

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Successful aneurysm treatment as defined by complete aneurysm angiographic occlusion without retreatment and no significant stenosis of the treated artery [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Parent artery patency [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • Any major stroke or death within 30 days , or ipsilateral stroke or neurological death within 12 months [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 151
Study Start Date: July 2013
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Device: LVIS
LVIS™ and LVIS™ Jr. MicroVention Low-profile Visualized Intraluminal Support Device
Device: LVIS™ and LVIS™ Jr
Other Name: Low Profile Visualized Intraluminal Support device

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01793792

Contacts
Contact: Mary Schmitz, MS 714 247-8025 mary.schmitz@microvention.com
Contact: Vinny Podichetty, MD 714 247-8043 vinny.podichetty@microvention.com

  Show 24 Study Locations
Sponsors and Collaborators
Microvention-Terumo, Inc.
Investigators
Principal Investigator: David Fiorella, M.D. Stony Brook University Medical Center
  More Information

No publications provided

Responsible Party: Microvention-Terumo, Inc.
ClinicalTrials.gov Identifier: NCT01793792     History of Changes
Other Study ID Numbers: CL11002, G110188/S004
Study First Received: February 14, 2013
Last Updated: August 7, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Microvention-Terumo, Inc.:
intracranial, saccular, aneurysms, stenting, coiling

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 September 18, 2014