FRED/ FRED Jr/ FRED X Intracranial Aneurysm Treatment Study (FRITS)

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

Study Overview

• Status: Active, not recruiting
• Conditions: Intracranial Aneurysm
• Intervention / Treatment: Device: FRED, FRED Jr and FRED X

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 Type: Observational
• Enrollment (Actual): 156

Contacts and Locations

Study Locations

• Germany
  • Erlangen, Germany, D-91054
    • Universitätsklinikum Erlangen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who are at least 18 years of age presenting with an unruptured or recanalized intracranial aneurysm requiring endovascular treatment. Those eligible to be treated with FRED/ FRED Jr/ FRED X will be enrolled after having signed an informed consent form.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Morbidity Rate	Patients with mRS>2	6 months
Mortality Rate	Deaths within 6 months after treatment	6 months

Collaborators and Investigators

• Sponsor: Microvention-Terumo, Inc.
• Investigators: Principal Investigator: Arnd Dörfler, Prof. Dr. med., Universitätsklinikum Erlangen

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 10, 2019
• Primary Completion (ANTICIPATED): December 30, 2023
• Study Completion (ANTICIPATED): December 30, 2027

Study Registration Dates

• First Submitted: April 15, 2019
• First Submitted That Met QC Criteria: April 17, 2019
• First Posted (ACTUAL): April 18, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 29, 2022
• Last Update Submitted That Met QC Criteria: April 28, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: CIP EMEA 18-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No