Intracranial AneurysmsLVISNCT01793792
Pivotal Study of the LVIS (Low Profile Visualized Intraluminal Support)
A study testing LVIS™ and LVIS™ Jr in people with Intracranial Aneurysms, run by Microvention-Terumo, Inc. at 21 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Intracranial Aneurysms
- What is being tested?
- LVIS™ and LVIS™ Jr
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 21 sitesUnited States
- Study dates
- Jul 2013to Jan 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
Albany Medical College
Albany, New York, 12208
University of Maryland
Baltimore, Maryland, 21201
Tufts Medical Center
Boston, Massachusetts, 02111
University at Buffalo Neurosurgery
Buffalo, New York, 14203
Dignity Health/Mercy San Juan Medical Center
Carmichael, California, 95608
Medical University of South Carolina
Charleston, South Carolina, 29425
Rush University Medical Center
Chicago, Illinois, 60612
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Colorado Neurological Institute
Englewood, Colorado, 80113
The Methodist Hospital
Houston, Texas, 77030
Indiana University/Methodist Research Institute
Indianapolis, Indiana, 46202
North Shore University Hospital
Manhasset, New York, 11030
Methodist University Hospital
Memphis, Tennessee, 38120
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407
University of Minnesota
Minneapolis, Minnesota, 55455
Vanderbilt University
Nashville, Tennessee, 37232
St. Luke's Roosevelt Hospital Center
New York, New York, 10019
Advocate Health and Hospital
Oak Lawn, Illinois, 60453
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15219
Stony Brook University Medical Center
Stony Brook, New York, 11794
About this study
Official title: Pivotal Study of the Microvention, Inc Neurovascular Self-Expanding Retrievable Stent System LVIS
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.
- Conditions
- Intracranial Aneurysms
- Being tested
- LVIS™ and LVIS™ Jr
- Keywords
- intracranial, saccular, aneurysms, stenting, coiling
- Medical subject headings
- Intracranial Aneurysm, Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LVIS™ and LVIS™ JrDevice
Also called Low Profile Visualized Intraluminal Support device
The LVIS Device is intended for use with embolization coils for the treatment of wide neck, intracranial aneurysms.
| Study group | Role | What they receive |
|---|---|---|
| Device: LVIS | Other | 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 Receives: Device: LVIS™ and LVIS™ Jr |
What is being measured
The primary outcome is the main question the study is designed to answer.
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"
Measured: 12 months
Primary Safety Composite Rate (Disabling Stroke With mRS Score Greater Than or Equal to 3, or Neurological Death Within 12 Months
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2013 (estimated)
- Study startJul 2013
- Primary completionNov 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intracranial AneurysmsStudies of the same condition, open and under way.
- More trials run by Microvention-Terumo, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Low Profile Visualized Intraluminal Support device
- Masking
- None (open label)
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Microvention-Terumo, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Fiorella, M.D., Principal investigator, Stony Brook University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01793792
- Sponsor's protocol ID
- CL11002
- Other IDs
- G110188/S004
- Acronym
- LVIS
- Status last verified
- Nov 2019
- First submitted
- 14 Feb 2013
- Last updated
- 22 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Fiorella D, Boulos A, Turk AS, Siddiqui AH, Arthur AS, Diaz O, Lopes DK; LVIS investigators. The safety and effectiveness of the LVIS stent system for the treatment of wide-necked cerebral aneurysms: final results of the pivotal US LVIS trial. J Neurointerv Surg. 2019 Apr;11(4):357-361. doi: 10.1136/neurintsurg-2018-014309. Epub 2018 Oct 8.
PubMed 30297543
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pivotal Study of the Microvention, Inc Neurovascular Self-Expanding Retrievable Stent System LVIS
- ClinicalTrials.gov ID
- NCT01793792
- Acronym / sponsor ID
- LVIS / CL11002
- Conditions
- Intracranial Aneurysms
- Keywords
- intracranial, saccular, aneurysms, stenting, coiling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Microvention-Terumo, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- Nov 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 18 Feb 2013 (estimated)
- Results
- Posted 27 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Low Profile Visualized Intraluminal Support device
| Arm | Type | Receives |
|---|---|---|
| Device: LVIS | Other | Device: LVIS™ and LVIS™ JrThe 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LVIS™ and LVIS™ JrAlso: Low Profile Visualized Intraluminal Support deviceThe LVIS Device is intended for use with embolization coils for the treatment of wide neck, intracranial aneurysms. | Device | Device: LVIS |
Primary outcome
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30297543Fiorella D, Boulos A, Turk AS, Siddiqui AH, Arthur AS, Diaz O, Lopes DK; LVIS investigators. The safety and effectiveness of the LVIS stent system for the treatment of wide-necked cerebral aneurysms: final results of the pivotal US LVIS trial. J Neurointerv Surg. 2019 Apr;11(4):357-361. doi: 10.1136/neurintsurg-2018-014309. Epub 2018 Oct 8.
- The safety and effectiveness of the LVIS stent system for the treatment of wide-necked cerebral aneurysms: final results of the pivotal US LVIS trial. Fiorella D, Boulos A, Turk AS, Siddiqui AH, Arthur AS, Diaz O, Lopes DK on behalf of LVIS InvestigatorsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Fiorella, M.D. principal investigator
Stony Brook University Medical Center
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LVIS™ and LVIS™ Jr in people with Intracranial Aneurysms, run by Microvention-Terumo, Inc. at 21 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01793792, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2025.