TRAIL: Treatment of Intracranial Aneurysms With LVIS® System

NCT02921711 | Completed DMC

• 1 other identifier: TRAIL
• Study Type: observational
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Intracranial Aneurysms

Outcome Measures

Primary Outcomes (8)

• 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

• Retreatment rate

  18 months

• Morbidity rate

  6 months

• Morbidity rate

  18 months

• Mortality rate

  6 months

• Mortality rate

  18 months

Study Arms (1)

LVIS®

Device: LVIS®

Interventions

LVIS® DEVICE

Low-profile Visualized Intraluminal Support device

LVIS®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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
• 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
• Patient is aged ≥ 18 years
• Patient presents with a WFNS score between 0 and 3
• Patient has agreed to attend follow-up appointments

You may not qualify if:

• The use of an endovascular stent other than LVIS® has been determined necessary
• Patient presents with medical or surgical co-morbidities limiting his/her life expectancy to less than one year
• Patient has a contraindication to platelet inhibition treatment
• Patient requires retreatment of an aneurysm previously treated with a stent
• Patient is pregnant
• Patient has multiple aneurysms to be treated in one procedure

Sponsors & Collaborators

• Microvention-Terumo, Inc.: lead

Related 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

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Charbel Mounayer, Prof.

  CHU Limoges; Limoges, France

  PRINCIPAL INVESTIGATOR

• Michel Piotin, M.D.

  Fondation Rothschild; Paris, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 18 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2016
• First Posted: October 3, 2016
• Study Start: June 1, 2012
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: January 7, 2025

Record last verified: 2025-01