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TRAIL: Treatment of Intracranial Aneurysms With LVIS® System

Sponsor
Microvention-Terumo, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02921711
Collaborator
(none)
90
Enrollment
46
Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: LVIS®

Study Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
90 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
TRAIL: Treatment of Intracranial Aneurysms With LVIS® System
Study Start Date :
Jun 1, 2012
Actual Primary Completion Date :
Apr 1, 2016
Actual Study Completion Date :
Apr 1, 2016

Arms and Interventions

Arm Intervention/Treatment
LVIS®

Device: LVIS®
Low-profile Visualized Intraluminal Support device

Outcome Measures

Primary Outcome Measures

  1. Anatomical stability of aneurysm treatment compared to the initial occlusion rate of the aneurysm [6 months]

  2. Anatomical stability of aneurysm treatment compared to the initial occlusion rate of the aneurysm [18 months]

  3. Retreatment rate [6 months]

  4. Retreatment rate [18 months]

  5. Morbidity rate [6 months]

  6. Morbidity rate [18 months]

  7. Mortality rate [6 months]

  8. Mortality rate [18 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

  1. Patient is aged ≥ 18 years

  2. Patient presents with a WFNS score between 0 and 3

  3. 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Microvention-Terumo, Inc.

Investigators

  • Principal Investigator: Charbel Mounayer, Prof., CHU Limoges; Limoges, France
  • Principal Investigator: Michel Piotin, M.D., Fondation Rothschild; Paris, France

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Microvention-Terumo, Inc.
ClinicalTrials.gov Identifier:
NCT02921711
Other Study ID Numbers:
  • TRAIL
First Posted:
Oct 3, 2016
Last Update Posted:
May 17, 2018
Last Verified:
Sep 1, 2016
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Additional relevant MeSH terms:
Intracranial Aneurysm
Aneurysm

Study Results

No Results Posted as of May 17, 2018