Intracranial Aneurysms
Conditions
Brief summary
A prospective, multicenter, observational assessment of the safety and effectiveness of the LVIS® device in the treatment of wide necked intracranial aneurysms.
Interventions
DEVICELVIS®
Low-profile Visualized Intraluminal Support device
Sponsors
Microvention-Terumo, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient or patient's legally authorized representative has been informed about the confidentiality of the study and has agreed to the collection of his/her personal data 2. Patient has a ruptured or unruptured intracranial aneurysm for which: * The parent artery has a diameter ≥ 2.0mm and ≤ 4.5 mm; * The aneurysm neck size is ≥ 4mm or its dome-to-neck ratio is \< 2 (wide neck) * Endovascular treatment with coils and one or more LVIS® devices has been determined necessary for the patient by the multidisciplinary team 3. Patient is aged ≥ 18 years 4. Patient presents with a WFNS score between 0 and 3 5. Patient has agreed to attend follow-up appointments
Exclusion criteria
1. The use of an endovascular stent other than LVIS® has been determined necessary 2. Patient presents with medical or surgical co-morbidities limiting his/her life expectancy to less than one year 3. Patient has a contraindication to platelet inhibition treatment 4. Patient requires retreatment of an aneurysm previously treated with a stent 5. Patient is pregnant 6. Patient has multiple aneurysms to be treated in one procedure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anatomical stability of aneurysm treatment compared to the initial occlusion rate of the aneurysm | 6 months |
| Retreatment rate | 6 months |
| Morbidity rate | 6 months |
| Mortality rate | 6 months |
Outcome results
None listed