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OpenTrials
Completed

NCT Number: NCT02921711

TRAIL: Treatment of Intracranial Aneurysms With LVIS® System

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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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

LVIS®

Device

Low-profile Visualized Intraluminal Support device

Primary outcomes

  1. Anatomical stability of aneurysm treatment compared to the initial occlusion rate of the aneurysm

    Time frame: 6 months

  2. Anatomical stability of aneurysm treatment compared to the initial occlusion rate of the aneurysm

    Time frame: 18 months

  3. Retreatment rate

    Time frame: 6 months

  4. Retreatment rate

    Time frame: 18 months

  5. Morbidity rate

    Time frame: 6 months

  6. Morbidity rate

    Time frame: 18 months

  7. Mortality rate

    Time frame: 6 months

  8. Mortality rate

    Time frame: 18 months

Sponsors and collaborators

Lead sponsor

Microvention-Terumo, Inc.

Industry

Registry information

Acronym: TRAIL

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Oct 3, 2016
Registry last updated
Jan 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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