TRAIL: Treatment of Intracranial Aneurysms With LVIS® System

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-06-30

Study Completion Date

2016-04-30

Brief Summary

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

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Detailed Description

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Conditions

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Intracranial Aneurysms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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LVIS®

Intervention Type DEVICE

Low-profile Visualized Intraluminal Support device

Interventions

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LVIS®

Low-profile Visualized Intraluminal Support device

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No