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The purpose of this study is to evaluate the safety and probable benefit of the Low-profile Visualized Intraluminal Support (LVISâ„¢ and LVISâ„¢ Jr.)devices from MicroVention, Inc. when used to facilitate endovascular coiling of unruptured wide-neck intracranial aneurysms with bare platinum embolization coils.
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 LVISâ„¢ 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Other | Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.) | Device | Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 30 days-6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Parent Artery Patency Measured Angiographically at 6 Months | To be assessed by Independent Core Lab. | 6 months |
| Successful Delivery of the LVISâ„¢ Device Measures by Technical Success | Technical success being defined as: access to the lesion, successful deployment of the LVISâ„¢ device. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Fiorella, M.D., Ph.D. | Stony Brook University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Albany Medical College | Albany | New York | 12208 | United States | ||
| Stony Brook University Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26391016 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Arm | Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.) Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.): Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 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. | 6 months |
| Stent Migration at 6 Months | Angiographic images will be comparing post procedure sent position to 6 months | 6 months |
| Device and Procedure Related Serious Adverse Events | All Serious Adverse events will be reported per protocol | 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. | Day 1-6 months |
| Stony Brook |
| New York |
| 11794 |
| United States |
| Thomas Jefferson Hospital | Philadelphia | Pennsylvania | 19107 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| UT Southwestern | Dallas | Texas | 75390 | United States |
| Methodist Hospital | Houston | Texas | 77030 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Arm | Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.) |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | percent occlusion of aneurysm | 6 months ± 4 weeks |
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| ||||||||||||||||||||||||||
| Primary | 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. | Posted | Number | patients | 30 days-6 months |
|
| ||||||||||||||||||||||||||||
| Secondary | Parent Artery Patency Measured Angiographically at 6 Months | To be assessed by Independent Core Lab. | Not Posted | 6 months | Participants | |||||||||||||||||||||||||||||||
| Secondary | Successful Delivery of the LVISâ„¢ Device Measures by Technical Success | Technical success being defined as: access to the lesion, successful deployment of the LVISâ„¢ device. | Not Posted | 24 hours | Participants | |||||||||||||||||||||||||||||||
| Secondary | 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. | Not Posted | 6 months | Participants | |||||||||||||||||||||||||||||||
| Secondary | Stent Migration at 6 Months | Angiographic images will be comparing post procedure sent position to 6 months | Not Posted | 6 months | Participants | |||||||||||||||||||||||||||||||
| Secondary | Device and Procedure Related Serious Adverse Events | All Serious Adverse events will be reported per protocol | Not Posted | Day 1-6months(± 4 months) | Participants | |||||||||||||||||||||||||||||||
| Secondary | 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. | Not Posted | Day 1-6 months | Participants |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Single Arm | Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.) | 1 | 31 | 8 | 31 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stroke/TIA | General disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | General disorders | Non-systematic Assessment |
| ||
| Hematoma at access site | General disorders | Systematic Assessment |
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| Stroke or TIA | General disorders | Systematic Assessment | non-serious |
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| Nausea | General disorders | Non-systematic Assessment |
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| Infection | Infections and infestations | Systematic Assessment |
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As part of a multi-center study the results of the national Trial shall be published by a National Principal Investigator within 12 months of completion of last study site. If no publication within that time frame, Principal Investigator is free to publish. Copies of proposed publication must be submitted to Sponsor at least 30 days in advance to ensure removal of proprietary or confidential information.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mary Schmitz | MicroVention, Inc. | 714-247-8025 | mary.schmitz@microvention.com |
| ID | Term |
|---|---|
| D002532 | Intracranial Aneurysm |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| >=65 years |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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