Intracranial Aneurysms
Conditions
Keywords
intracranial aneurysm, wide-neck, saccular, endovascular treatment, coil embolization, stent, bare platinum
Brief 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.
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.
Interventions
DEVICELow profile Visualized Intraluminal Device (LVIS and LVIS Jr.)
Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.)
Sponsors
Microvention-Terumo, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Probable Benefit Measures as Successful Aneurysm Treatment With the LVIS™ Device, as Measured by Aneurysm Angiographic Occlusion of ≥ 90% at 6 Months (± 4 Weeks) | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Significant Stenosis(>50%) of the Treated Artery at 6 Months | 6 months | Parent Artery will be measured baseline and compared at 6 months post procedure per review by the Independent Core Lab. |
| Stent Migration at 6 Months | 6 months | Angiographic images will be comparing post procedure sent position to 6 months |
| Parent Artery Patency Measured Angiographically at 6 Months | 6 months | To be assessed by Independent Core Lab. |
| Unplanned Embolization Coiling Within 6 Months | Day 1-6 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. |
| Device and Procedure Related Serious Adverse Events | Day 1-6months(± 4 months) | All Serious Adverse events will be reported per protocol |
| Successful Delivery of the LVIS™ Device Measures by Technical Success | 24 hours | Technical success being defined as: access to the lesion, successful deployment of the LVIS™ device. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Single Arm Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.) | 31 |
| Total | 31 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | alternate stent used | 1 |
| Overall Study | enrolled after study closed | 1 |
| Overall Study | excluded - metal allergy | 1 |
| Overall Study | GI bleed prior to procedure | 1 |
| Overall Study | stent not required | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Single Arm |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 11 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants |
| Age, Continuous | 58.6 years STANDARD_DEVIATION 10.6 |
| Region of Enrollment United States | 31 participants |
| Sex: Female, Male Female | 23 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 8 / 31 |
| serious Total, serious adverse events | 1 / 31 |
Outcome results
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.
Time frame: 6 months ± 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Arm | Probable Benefit Measures as Successful Aneurysm Treatment With the LVIS™ Device, as Measured by Aneurysm Angiographic Occlusion of ≥ 90% at 6 Months (± 4 Weeks) | 95 percent occlusion of aneurysm | Standard Deviation 19 |
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.
Time frame: 30 days-6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Single Arm | Safety Measures as Any Major Stroke or Death Within 30 Days, or Major Ipsi-lateral Stroke or Neurological Death Within 6 Months | 0 patients |
Secondary
Device and Procedure Related Serious Adverse Events
All Serious Adverse events will be reported per protocol
Time frame: Day 1-6months(± 4 months)
Secondary
Parent Artery Patency Measured Angiographically at 6 Months
To be assessed by Independent Core Lab.
Time frame: 6 months
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.
Time frame: 6 months
Secondary
Stent Migration at 6 Months
Angiographic images will be comparing post procedure sent position to 6 months
Time frame: 6 months
Secondary
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.
Time frame: 24 hours
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.
Time frame: Day 1-6 months