FRED/ FRED Jr/ FRED X Intracranial Aneurysm Treatment Study

Intracranial Aneurysm Clinical Trial

— FRITS  

Official title:

FRED/ FRED Jr/ FRED X Intracranial Aneurysm Treatment Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03920358
• Other study ID #: CIP EMEA 18-01
• Status: Active, not recruiting
• Start date: April 10, 2019
• Est. completion date: December 30, 2027

Study information

• Verified date: April 2022
• Source: Microvention-Terumo, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

This is a multi-center observational study. Treatment and follow-up visits will be performed as per standard of care. The purpose of this study is to demonstrate that use of the FRED/ FRED Jr/ FRED X Embolic device in intracranial aneurysm treatment is safe and effective when assessed at 6, 12 months and yearly up to 5 years post procedure. 150 patients will be enrolled over an 15-month recruitment period. All patients will be followed for 5 years.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 156
• Est. completion date: December 30, 2027
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patient older than 18 years old

2. Patient harboring a non-acutely ruptured intracranial aneurysm within the last 30 days

of presentation:

• for which use of FRED, FRED Jr or FRED X has been deemed appropriate
• being the only aneurysm to require treatment within the next 12 months
• and optionally previously treated by surgery (clipping) or with an intrasaccular device: aneurysm recanalized

3. Patient with a modified Rankin Scale (mRS) = 2

4. Patient has received information about data collection and has signed and dated an Informed Consent Form

Exclusion Criteria:

1. Patient has suffered from an ICH within the 30 days prior to the procedure.

2. The aneurysm to be treated is associated with a cAVM

3. The aneurysm to be treated is in the posterior circulation

4. The aneurysm to be treated has a stenosis of its parent artery >50%

5. Patient has another aneurysm previously treated with a stent or a flow diverter

• on the same parent vessel at any time
• on a different parent vessel, less than 3 months prior to the procedure (previously-implanted stents in the non-index proximal carotid are acceptable)

6. Patient with whom anticoagulant, antiplatelet or thrombolytic drugs are contra-indicated or test performed regarding AP medication administered is not efficient for the patient

7. Patient with known hypersensitivity to contrast products or nickel titanium, not treatable

8. Pregnancy or child breastfeeding

9. Patient unable or unlikely to complete required follow up

10. Patient has severe or fatal comorbidity or a life expectancy of less than 1 year

11. Treatment with a flow diverter other than FRED/ FRED Jr/ FRED X or in addition to FRED/ FRED Jr/ FRED X is planned

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm

Intervention

Device:
• FRED, FRED Jr and FRED X
Subjects aged = 18 requiring treatment for an unruptured or recanalized intracranial aneurysm

Locations

Country	Name	City	State
Germany	Universitätsklinikum Erlangen	Erlangen

Sponsors (1)

Lead Sponsor	Collaborator
Microvention-Terumo, Inc.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of complete aneurysm occlusion without associated stenosis of the parent artery (> 50%)	Complete occlusion (Raymond Scale grade I) without stenosis of the parent artery.; Raymond scale definition: Grade I= complete occlusion of aneurysm, Grade II= Residual neck, Grade III= Residual aneurysm	12 months
Primary	Morbidity Rate	Patients with mRS>2	6 months
Primary	Mortality Rate	Deaths within 6 months after treatment	6 months