Clinical trial NCT05453240: Post-Market Surveillance Study to Evaluate the Long-Term Safety and Effectiveness of the LVIS Device
Official title: Post-Approval Study - Post-Market Surveillance Study to Evaluate the Long-Term Safety and Effectiveness of the LVIS® Device
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Intracranial Aneurysms
Lead sponsor: Microvention-Terumo, Inc.
Sponsor class: INDUSTRY
First posted: 2022-07-12
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population conforms to currently approved Indications for Use: Subjects with wide-necked (neck ≥ 4 mm or dome to neck ratio \< 2) intracranial, saccular aneurysms arising from a parent vessel with a diameter ≥ 2.0 mm and ≤ 4.5 mm who underwent treatment with LVIS device since approval in the local geography of researched sizes.

Brief summary: The proposed study is a multi-center single arm retrospective and prospective data collection, of patients treated with the LVIS device of specific sizes of 3.5mm, 4.0mm, 4.5mm, 5.5mm with up to 5 years follow-up. Information collected during the study will be standardized across centers to include pre-treatment baseline characteristics of patients including aneurysm(s) symptoms, procedural information, prespecified clinical safety events of interest, and follow-up imaging, clinical visits or telephone calls.


Eligibility criteria: Inclusion Criteria:

The following criteria match the FDA-approved indications for use per PMA (P170013)

* Subjects treated with the LVIS® Device in accordance with currently approved indications for use;
* Treatment of wide-necked (neck ≥ 4mm or dome to neck ratio \< 2) intracranial saccular aneurysm arising from a parent vessel with a diameter ≥ 2.0 mm and ≤ 4.5 mm who underwent treatment with LVIS device of researched sizes within the last 5 years.

(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);

* Availability of Medical Health Records;
* Subject whose age is ≥ 18;
* Appropriate or Waived Consent:

  1. For retrospective review: Local Institutional Review Board approves the research as exempt, allowing an all-inclusive retrospective examination of medical records documenting treatments using the study devices and available clinical and imaging follow up;
  2. For prospective follow up: Subject or his/her Legally Authorized Representative consents to participation in the study follow up visits up to 5 years, and provides a signed informed consent form as applicable;.

Exclusion Criteria:

* Subjects not treated according to the currently approved indications for use

Primary outcomes:
measure: Complete or Stable Raymond Roy II
timeFrame: 5 year
measure: Intracranial hemorrhage including SAH and IPH
timeFrame: 5 year
measure: All ischemic and hemorrhagic stroke
timeFrame: 5 year
measure: Neurological deaths
timeFrame: 5 year
measure: Transient Ischemic Attack
timeFrame: 5 year
measure: Parent artery patency
timeFrame: 5 year
measure: In-stent stenosis
timeFrame: 5 year
measure: Target aneurysm retreatment
timeFrame: 5 year
measure: Cerebral vasospasm
timeFrame: 5 year
Secondary outcomes:
Other outcomes:
Locations:
city: Aliso Viejo
country: United States
facility: Microvention
state: California
Study officials:
References: