Intracranial Aneurysms
Conditions
Keywords
intracranial, saccular, aneurysms, stenting, coiling
Brief 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.
Interventions
DEVICELVIS™ and LVIS™ Jr
The LVIS Device is intended for use with embolization coils for the treatment of wide neck, intracranial aneurysms.
Sponsors
Microvention-Terumo, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Low Profile Visualized Intraluminal Support device
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Device: LVIS LVIS™ and LVIS™ Jr: The LVIS Device is intended for use with embolization coils for the treatment of wide neck, intracranial aneurysms. | 153 |
| Total | 153 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 5 |
| Overall Study | Device Not Implanted | 1 |
| Overall Study | Lost to Follow-up | 5 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Device: LVIS |
|---|---|
| Age, Continuous | 58.3 Years STANDARD_DEVIATION 10.49 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 24 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 123 Participants |
| Sex: Female, Male Female | 110 Participants |
| Sex: Female, Male Male | 43 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 6 / 153 |
| other Total, other adverse events | 15 / 153 |
| serious Total, serious adverse events | 48 / 153 |
Outcome results
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
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device: LVIS | 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 | 108 Participants |
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device: LVIS | Primary Safety Composite Rate (Disabling Stroke With mRS Score Greater Than or Equal to 3, or Neurological Death Within 12 Months | 9 Participants |