TRAIL: Treatment of Intracranial Aneurysms With LVIS® System

Intracranial Aneurysms Clinical Trial

— TRAIL  

Official title:

TRAIL: Treatment of Intracranial Aneurysms With LVIS® System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02921711
• Other study ID #: TRAIL
• Status: Completed
• Start date: June 2012
• Est. completion date: April 2016

Study information

• Verified date: September 2016
• Source: Microvention-Terumo, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm
• Intracranial Aneurysms

Intervention

Device:
• LVIS®
Low-profile Visualized Intraluminal Support device

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Microvention-Terumo, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anatomical stability of aneurysm treatment compared to the initial occlusion rate of the aneurysm		6 months
Primary	Anatomical stability of aneurysm treatment compared to the initial occlusion rate of the aneurysm		18 months
Primary	Retreatment rate		6 months
Primary	Retreatment rate		18 months
Primary	Morbidity rate		6 months
Primary	Morbidity rate		18 months
Primary	Mortality rate		6 months
Primary	Mortality rate		18 months