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| ID | Type | Description | Link |
|---|---|---|---|
| G110188/S004 | Other Identifier | FDA |
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The purpose of this study is to evaluate the safety and efficacy of the Low Profile Visualized Intraluminal Support(LVISâ„¢ and LVISâ„¢ Jr.)devices from MicroVention, Inc. when used to facilitate endovascular coiling of wide-necked intracranial aneurysms with coils.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Device: LVIS | Other | The LVIS Device is intended for use with embolization coils for the treatment of wide neck, intracranial aneurysms. Device: LVISâ„¢ and LVISâ„¢ Jr. MicroVention Low-profile Visualized Intraluminal Support Device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LVISâ„¢ and LVISâ„¢ Jr | Device | The LVIS Device is intended for use with embolization coils for the treatment of wide neck, intracranial aneurysms. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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" | 12 months | |
| Primary Safety Composite Rate (Disabling Stroke With mRS Score Greater Than or Equal to 3, or Neurological Death Within 12 Months | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Fiorella, M.D. | Stony Brook University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Joseph's Hospital and Medical Center | Phoenix | Arizona | 85013 | United States | ||
| Dignity Health/Mercy San Juan Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30297543 | Derived | 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. |
| Label | URL |
|---|---|
| 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 Investigators | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Device: LVIS | Device: LVISâ„¢ and LVISâ„¢ Jr. MicroVention Low-profile Visualized Intraluminal Support Device |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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Low Profile Visualized Intraluminal Support device
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| Carmichael |
| California |
| 95608 |
| United States |
| Colorado Neurological Institute | Englewood | Colorado | 80113 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| Advocate Health and Hospital | Oak Lawn | Illinois | 60453 | United States |
| Indiana University/Methodist Research Institute | Indianapolis | Indiana | 46202 | United States |
| University of Maryland | Baltimore | Maryland | 21201 | United States |
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| Abbott Northwestern Hospital | Minneapolis | Minnesota | 55407 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| Albany Medical College | Albany | New York | 12208 | United States |
| University at Buffalo Neurosurgery | Buffalo | New York | 14203 | United States |
| North Shore University Hospital | Manhasset | New York | 11030 | United States |
| St. Luke's Roosevelt Hospital Center | New York | New York | 10019 | United States |
| Stony Brook University Medical Center | Stony Brook | New York | 11794 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15219 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Methodist University Hospital | Memphis | Tennessee | 38120 | United States |
| Vanderbilt University | Nashville | Tennessee | 37232 | United States |
| The Methodist Hospital | Houston | Texas | 77030 | United States |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Device: LVIS | LVISâ„¢ and LVISâ„¢ Jr: The LVIS Device is intended for use with embolization coils for the treatment of wide neck, intracranial aneurysms. |
| 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 |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | 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 | 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" | Posted | Count of Participants | Participants | 12 months |
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| Primary | Primary Safety Composite Rate (Disabling Stroke With mRS Score Greater Than or Equal to 3, or Neurological Death Within 12 Months | Posted | Count of Participants | Participants | 12 months |
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1 year
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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 | Device: LVIS | LVISâ„¢ and LVISâ„¢ Jr: The LVIS Device is intended for use with embolization coils for the treatment of wide neck, intracranial aneurysms. | 6 | 153 | 48 | 153 | 15 | 153 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Aneurysm rupture | Nervous system disorders | Systematic Assessment |
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| Aphasia | Nervous system disorders | Systematic Assessment |
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| Dissection or perforation of the parent artery | Nervous system disorders | Systematic Assessment |
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| Hydrocephalus | Nervous system disorders | Systematic Assessment |
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| Intra-Parenchymal Hemorrhage (IPH) | Nervous system disorders | Systematic Assessment |
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| Neurological deficits | Nervous system disorders | Systematic Assessment |
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| Seizure | Nervous system disorders | Systematic Assessment |
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| Stent Thrombosis | Nervous system disorders | Systematic Assessment |
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| Stroke | Nervous system disorders | Systematic Assessment |
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| Sub-Arachnoid Hemorrhage (SAH) | Nervous system disorders | Systematic Assessment |
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| Sub-Dural Hematoma (SDH) | Nervous system disorders | Systematic Assessment |
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| TIA (Transient Ischemic Attack) | Nervous system disorders | Systematic Assessment |
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| Target aneurysm retreatment | Surgical and medical procedures | Systematic Assessment |
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| Thromboembolic event | Nervous system disorders | Systematic Assessment |
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| Vasospasm | Nervous system disorders | Systematic Assessment |
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| Visual impairment | Eye disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anne Hurley | MicroVention, Inc | 714-247-8000 | anne.hurley@microvention.com |
| ID | Term |
|---|---|
| D002532 | Intracranial Aneurysm |
| D000783 | Aneurysm |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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