Intracranial Aneurysms Clinical Trial
— LVISOfficial title:
Pivotal Study of the Microvention, Inc Neurovascular Self-Expanding Retrievable Stent System LVIS
| Verified date | November 2019 |
| Source | Microvention-Terumo, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 153 |
| Est. completion date | January 2016 |
| Est. primary completion date | November 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Albany Medical College | Albany | New York |
| United States | University of Maryland | Baltimore | Maryland |
| United States | Tufts Medical Center | Boston | Massachusetts |
| United States | University at Buffalo Neurosurgery | Buffalo | New York |
| United States | Dignity Health/Mercy San Juan Medical Center | Carmichael | California |
| United States | Medical University of South Carolina | Charleston | South Carolina |
| United States | Rush University Medical Center | Chicago | Illinois |
| United States | Cleveland Clinic Foundation | Cleveland | Ohio |
| United States | Colorado Neurological Institute | Englewood | Colorado |
| United States | The Methodist Hospital | Houston | Texas |
| United States | Indiana University/Methodist Research Institute | Indianapolis | Indiana |
| United States | North Shore University Hospital | Manhasset | New York |
| United States | Methodist University Hospital | Memphis | Tennessee |
| United States | Abbott Northwestern Hospital | Minneapolis | Minnesota |
| United States | University of Minnesota | Minneapolis | Minnesota |
| United States | Vanderbilt University | Nashville | Tennessee |
| United States | St. Luke's Roosevelt Hospital Center | New York | New York |
| United States | Advocate Health and Hospital | Oak Lawn | Illinois |
| United States | St. Joseph's Hospital and Medical Center | Phoenix | Arizona |
| United States | University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania |
| United States | Stony Brook University Medical Center | Stony Brook | New York |
| Lead Sponsor | Collaborator |
|---|---|
| Microvention-Terumo, Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| 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" | 12 months | ||
| Primary | 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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