|
|
| General |
| Study Status |
Delayed |
Application Number /
Requirement Number |
P170013 / PAS001 |
| Date Original Protocol Accepted |
11/17/2020
|
| Date Current Protocol Accepted |
08/21/2024
|
| Study Name |
PAS-Post-Market Surveillance Study/LongTerm Safety
|
| Device Name |
Low-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr.
|
| Clinical Trial Number(s) |
NCT01793792
|
| General Study Protocol Parameters |
| Study Design |
Prospective & Retrospective Study
|
| Data Source |
Sponsor Registry
|
| Comparison Group |
No Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Transit.Adolescent B(as adults): 18 yrs < 22 yrs,
Adult: At least 22 yrs
|
| Detailed Study Protocol Parameters |
| Study Objectives |
A multi-center, real-world evidence (RWE), single arm, retrospective and prospective study
|
| Study Population |
The study population conforms to currently approved Indications for Use: Subjects with wide-necked (neck greater than or equal to 4 mm or dome to neck ratio < 2) intracranial, saccular aneurysms arising from a parent vessel with a diameter greater than or equal to 2.0 mm and less than or equal to 4.5 mm who underwent treatment with LVIS device since approval in the local geography of researched sizes.
Real-world data (RWD) will be collected from Medical Health Records of LVIS Device treatments for all patients who meet eligibility criteria and who were treated with the LVIS device sizes per protocol. At least 10 and no more than 35 subjects from each site that meet criteria will be included in the study to obtain data from at least 250 subjects. To mitigate bias, the records of consecutive patients will be screened to assess eligibility.
|
| Sample Size |
To mitigate selection bias, all LVIS sites under HDE (HDE # H130005) and the LVIS IDE pivotal study that treated greater than or equal to 10 and no more than 35 patients with LVIS Device models: 212517-LVIS, 212525-LVIS, 213015-LVIS, 213025-LVIS, 213041-LVIS, 214035-LVIS, 214049-LVIS; 212912-LVIS, 212917-LVIS, 212922-LVIS, 212928-LVIS, and 212931-LVIS, will be asked to participate in this study.
Sites that treated patients with these LVIS device models since PMA approval may also be approached for participation.
|
| Key Study Endpoints |
All safety and effectiveness clinical outcomes will be prospectively reviewed in detail with an independent Clinical Events Committee, comprised of 3 members. The committee shall determine the event category using the following a priori clinical outcomes:
1. Complete or stable Raymond-Roy II intracranial aneurysm occlusion
2. Intracranial hemorrhage including SAH and IPH
3. All ischemic and hemorrhagic strokes
4. Neurological deaths
5. Transient Ischemic Attacks (TIAs)
6. Parent artery patency
7. In-stent stenosis
8. Target aneurysm retreatment
9. Cerebral vasospasm
|
| Follow-up Visits and Length of Follow-up |
Up to 5 years post-implant
|
