TRAIL: Treatment of Intracranial Aneurysms With LVIS® System

Completed

• Conditions: Intracranial Aneurysms
• Interventions: Device: LVIS®

• Registration Number: NCT02921711
• Lead Sponsor: Microvention-Terumo, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Study First Submitted: 2016-09-27
• Study First Submitted QC: 2016-09-29
• Study First Posted: 2016-10-03
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-06
• Last Update Posted: 2025-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
LVIS®	LVIS®	-

Primary Outcome Measures

Name	Time	Method
Anatomical stability of aneurysm treatment compared to the initial occlusion rate of the aneurysm	18 months
Retreatment rate	18 months
Mortality rate	18 months
Morbidity rate	18 months