Safety and Efficacy Analysis of FRED® Embolic Device in Aneurysm Treatment

Intracranial Aneurysms Clinical Trial

— SAFE  

Official title:

Safety and Efficacy Analysis of FRED® Embolic Device in Aneurysm Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02921698
• Other study ID #: SAFE
• Status: Completed
• Start date: July 2014
• Est. completion date: December 2017

Study information

• Verified date: August 2017
• Source: Microvention-Terumo, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

A prospective, multicenter, observational evaluation of the safety and efficacy of the FRED® device in the treatment of intracranial aneurysms.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patient is aged =18 years

2. Patient has an unruptured or recanalized intracranial aneurysm :

• for which an endovascular treatment has been determined appropriate

• that can not be treated by standard techniques (coiling with or without remodeling)

• and for which the FRED® Flow Diverter has been determined an appropriate treatment

3. Patient or patient's legally authorized representative has been informed about the confidentiality of the study and agrees to the collection of his/her personal data

4. Patient presents with an mRS score between 0 and 2

5. Patients who have already been treated with a stent or a flow diverter for another aneurysm may be included if:

• the previous treatment was more than three months prior to enrollment in this study

• the aneurysm to be treated for this study is a new aneurysm located on a different parent vessel unless the stent already in place is implanted on the proximal carotid artery.

Exclusion Criteria:

1. Patient has a known allergy to antiplatelet therapy, heparin and/or contrast medium

2. Patient has contraindication to antiplatelet therapy and/or heparin

3. Patient is pregnant and/or breastfeeding

4. Patient may not benefit from imaging and clinical monitoring

5. Patient has a medical or surgical co-morbidities limiting his/her life expectancy to less than 1 year

6. Patient will be treated with a flow diverter other than FRED®

7. Patient had an intracranial hemorrhage within the 30 days preceding treatment

8. Patient has an aneurysm(s) with one or more of the following characteristics:

• associated with an arteriovenous malformation

• dissecting or ""blister-like""

• multiple (unless only one aneurysm requires treatment)

• located in the posterior circulation

• treated with a stent or a flow diverter on the same parent vessel (excluding proximal carotid artery) or in the 3 months prior to inclusion

9. Patient has stenosis of the aneurysm parent artery.

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm
• Intracranial Aneurysms

Intervention

Device:
• FRED®
Flow Re-Direction Endoluminal 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	Aneurysm occlusion without ? 50% parent artery stenosis		6 months
Primary	Morbidity rate		6 months
Primary	Mortality rate		6 months