TRAIL: Treatment of Intracranial Aneurysms With LVIS® System

MicroVention

Status: Completed

Conditions: Intracranial Aneurysms

Treatments: Device: LVIS®

Study type: Observational

Funder types: Industry

Identifiers

NCT02921711

TRAIL

Details and patient eligibility

About

A prospective, multicenter, observational assessment of the safety and effectiveness of the LVIS® device in the treatment of wide necked intracranial aneurysms.

Enrollment: 90 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

90 participants in 1 patient group

LVIS®

Treatment:

Device: LVIS®