TRAIL: Treatment of Intracranial Aneurysms With LVIS® System

NCT02921711•Microvention-Terumo, Inc.

Summary

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

Eligibility

Age

18 - No limit years

Sex

ALL

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

Key Dates

Start Date

June 1, 2012

Primary Completion Date

April 1, 2016

Completion Date

April 1, 2016

Last Updated

January 7, 2025

Enrollment

ACTUAL participants

Conditions

Intracranial Aneurysms

Interventions

LVIS®

DEVICE

Targeting Real World Usage In Stroke Treatment

NCT07474935

Saccular and Fusiform AneurysmsPseudoaneurysm+7 more

View study

COMPLETEDNA

The WEB-IT Clinical Study

NCT02191618

Wide Neck Bifurcation Intracranial AneurysmsIntracranial Aneurysms

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 7, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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TRAIL: Treatment of Intracranial Aneurysms With LVIS® System

Inclusion Criteria

Exclusion Criteria

Targeting Real World Usage In Stroke Treatment

The WEB-IT Clinical Study

Treatment of Intracranial Wide-neck Aneurysms Using Stent-assisted Coil Embolization

Analysis of Thrombo-embolic Complications After Endovascular Treatment of Unruptured Intracranial Aneurysms

Pivotal Study of the FRED Stent System in the Treatment of Intracranial Aneurysms

TransForm™ Occlusion Balloon Catheter Registry