FRED/ FRED Jr/ FRED X Intracranial Aneurysm Treatment Study

Active, not recruiting

• Conditions: Intracranial Aneurysm

• Registration Number: NCT03920358
• Lead Sponsor: Microvention-Terumo, Inc.

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2019-04-10
• Study First Submitted: 2019-04-15
• Study First Submitted QC: 2019-04-17
• Study First Posted: 2019-04-18
• Primary Completion: 2023-06-09
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-07
• Last Update Posted: 2025-01-08
• Study Completion: 2027-12-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 156

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of complete aneurysm occlusion without associated stenosis of the parent artery (> 50%)	12 months	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
Mortality Rate	6 months	Deaths within 6 months after treatment
Morbidity Rate	6 months	Patients with mRS\>2

Trial Locations

Locations (1)

Universitätsklinikum Erlangen; 🇩🇪 Erlangen, Germany