Intracranial AneurysmsPhase 2/3LVISNCT01541254
Feasibility Study of the LVIS™ (Low-profile Visualized Intraluminal Support)Device
A Phase 2/3 study testing Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.) in people with Intracranial Aneurysms, run by Microvention-Terumo, Inc. at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intracranial Aneurysms
- What is being tested?
- Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 6 sitesUnited States
- Study dates
- Mar 2012to Jun 2013
- Phase
- Phase 2/3
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Albany Medical College
Albany, New York, 12208
Medical University of South Carolina
Charleston, South Carolina, 29425
UT Southwestern
Dallas, Texas, 75390
Methodist Hospital
Houston, Texas, 77030
Thomas Jefferson Hospital
Philadelphia, Pennsylvania, 19107
Stony Brook University Medical Center
Stony Brook, New York, 11794
About this study
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
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.
Read the 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.
- Conditions
- Intracranial Aneurysms
- Being tested
- Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.)
- Keywords
- intracranial aneurysm, wide-neck, saccular, endovascular treatment, coil embolization, stent, bare platinum
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.)Device
Also called Low-profile Vizualized Intraluminal Support Device
Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.)
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Other | Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.) Receives: Device: Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probable Benefit Measures as Successful Aneurysm Treatment With the LVIS™ Device, as Measured by Aneurysm Angiographic Occlusion of ≥ 90% at 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.
Measured: 6 months ± 4 weeks
Safety Measures as Any Major Stroke or Death Within 30 Days, or Major Ipsi-lateral Stroke or Neurological Death Within 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.
Measured: 30 days-6 months
Secondary outcomes (6)
Parent Artery Patency Measured Angiographically at 6 Months
To be assessed by Independent Core Lab.
Measured: 6 months
Successful Delivery of the LVIS™ Device Measures by Technical Success
Technical success being defined as: access to the lesion, successful deployment of the LVIS™ device.
Measured: 24 hours
Significant Stenosis(>50%) of the Treated Artery at 6 Months
Parent Artery will be measured baseline and compared at 6 months post procedure per review by the Independent Core Lab.
Measured: 6 months
Stent Migration at 6 Months
Angiographic images will be comparing post procedure sent position to 6 months
Measured: 6 months
Device and Procedure Related Serious Adverse Events
All Serious Adverse events will be reported per protocol
Measured: Day 1-6months(± 4 months)
Unplanned Embolization Coiling Within 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.
Measured: Day 1-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2012 (estimated)
- Study startMar 2012
- Primary completionJun 2013
- Study completionJun 2013
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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Microvention-Terumo, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Fiorella, M.D., Ph.D., Principal investigator, Stony Brook University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01541254
- Sponsor's protocol ID
- G110014
- Acronym
- LVIS
- Status last verified
- Jun 2025
- First submitted
- 15 Feb 2012
- Last updated
- 1 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Fiorella D, Arthur A, Boulos A, Diaz O, Jabbour P, Pride L, Turk AS, Woo HH, Derdeyn C, Millar J, Clifton A. Final results of the US humanitarian device exemption study of the low-profile visualized intraluminal support (LVIS) device. J Neurointerv Surg. 2016 Sep;8(9):894-7. doi: 10.1136/neurintsurg-2015-011937. Epub 2015 Sep 21.
PubMed 26391016
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01541254
- Acronym / sponsor ID
- LVIS / G110014
- Conditions
- Intracranial Aneurysms
- Keywords
- intracranial aneurysm, wide-neck, saccular, endovascular treatment, coil embolization, stent, bare platinum
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Microvention-Terumo, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 29 Feb 2012 (estimated)
- Results
- Posted 15 Sep 2014
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 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.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Other | Device: Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.)Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- 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
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 |
|---|---|---|
| Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.)Also: Low-profile Vizualized Intraluminal Support DeviceLow profile Visualized Intraluminal Device (LVIS and LVIS Jr.) | Device | Single Arm |
Primary outcome
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.
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.
6 secondary outcomes
Parent Artery Patency Measured Angiographically at 6 Months
Time frame: 6 months
Successful Delivery of the LVIS™ Device Measures by Technical Success
Time frame: 24 hours
Significant Stenosis(>50%) of the Treated Artery at 6 Months
Time frame: 6 months
Stent Migration at 6 Months
Time frame: 6 months
Device and Procedure Related Serious Adverse Events
Time frame: Day 1-6months(± 4 months)
Unplanned Embolization Coiling Within 6 Months
Time frame: Day 1-6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26391016Fiorella D, Arthur A, Boulos A, Diaz O, Jabbour P, Pride L, Turk AS, Woo HH, Derdeyn C, Millar J, Clifton A. Final results of the US humanitarian device exemption study of the low-profile visualized intraluminal support (LVIS) device. J Neurointerv Surg. 2016 Sep;8(9):894-7. doi: 10.1136/neurintsurg-2015-011937. Epub 2015 Sep 21.
Related trials for Intracranial Aneurysms
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
RecruitingObservational study
Determining the Clinical Impact and Prevalence of Hemorrhagic Subtypes in Perimesencephalic Subarachnoid Hemorrhage
Subarachnoid Hemorrhage, Spontaneous, Subarachnoid Hemorrhage, Aneurysmal
Not yet recruitingPhase 1/2
Induced Suppression of Platelet Activity in Aneurysmal Subarachnoid Hemorrhage Management-2 (iSPASM-2)
Aneurysmal Subarachnoid Hemorrhage
RecruitingObservational study
A Study of Choydar Flow-Directed Mesh Stent in the Treatment of Unruptured Intracranial Aneurysms
Intracranial Aneurysm
Not yet recruiting
Effect of Bilateral Greater Occipital Nerve Block on Headache After Intracranial Aneurysm Coiling
Intracranial Aneurysm, Postoperative Pain
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., Ph.D. principal investigator
Stony Brook University Medical Center
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.) in people with Intracranial Aneurysms, run by Microvention-Terumo, Inc. at 6 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 5 inclusion and 14 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 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Sep 2014). 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?
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). 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 NCT01541254, 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 1 Jul 2025.