TRAIL: Treatment of Intracranial Aneurysms With LVIS® System (TRAIL)

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

Study Overview

• Status: Completed
• Conditions: Intracranial Aneurysms
• Intervention / Treatment: Device: LVIS®

• Study Type: Observational
• Enrollment (Actual): 90

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients aged minimum of 18 years with an intracranial aneurysm in whom stent-assisted coiling has been determined to be the appropriate treatment strategy.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
LVIS®	Device: LVIS®; Low-profile Visualized Intraluminal Support device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mortality rate	6 months
Retreatment rate	18 months
Anatomical stability of aneurysm treatment compared to the initial occlusion rate of the aneurysm	6 months
Anatomical stability of aneurysm treatment compared to the initial occlusion rate of the aneurysm	18 months
Retreatment rate	6 months
Morbidity rate	6 months
Morbidity rate	18 months
Mortality rate	18 months

Collaborators and Investigators

• Sponsor: Microvention-Terumo, Inc.
• Investigators: Principal Investigator: Charbel Mounayer, Prof., CHU Limoges; Limoges, France; Principal Investigator: Michel Piotin, M.D., Fondation Rothschild; Paris, France

Publications and helpful links

Helpful Links

• Safety and effectiveness of the Low Profile Visualized Intraluminal Support (LVIS and LVIS Jr) devices in the endovascular treatment of intracranial aneurysms: results of the TRAIL multicenter observational study

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: September 27, 2016
• First Submitted That Met QC Criteria: September 29, 2016
• First Posted (Estimated): October 3, 2016

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 6, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: TRAIL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED