FRED/ FRED Jr/ FRED X Intracranial Aneurysm Treatment Study

NCT03920358 | Active Not Recruiting DMC

• 1 other identifier: CIP EMEA 18-01
• Study Type: observational
• Target: 156
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Intracranial Aneurysm

Outcome Measures

Primary Outcomes (3)

• 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

Interventions

FRED, FRED Jr and FRED X DEVICE

Subjects aged ≥ 18 requiring treatment for an unruptured or recanalized intracranial aneurysm

Also known as: Flow Re-Direction Endoluminal Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patient older than 18 years old
• 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
• Patient with a modified Rankin Scale (mRS) ≤ 2
• Patient has received information about data collection and has signed and dated an Informed Consent Form

You may not qualify if:

• Patient has suffered from an ICH within the 30 days prior to the procedure.
• The aneurysm to be treated is associated with a cAVM
• The aneurysm to be treated is in the posterior circulation
• The aneurysm to be treated has a stenosis of its parent artery \>50%
• 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)
• Patient with whom anticoagulant, antiplatelet or thrombolytic drugs are contra-indicated or test performed regarding AP medication administered is not efficient for the patient
• Patient with known hypersensitivity to contrast products or nickel titanium, not treatable
• Pregnancy or child breastfeeding
• Patient unable or unlikely to complete required follow up
• Patient has severe or fatal comorbidity or a life expectancy of less than 1 year
• Treatment with a flow diverter other than FRED/ FRED Jr/ FRED X or in addition to FRED/ FRED Jr/ FRED X is planned

Sponsors & Collaborators

• Microvention-Terumo, Inc.: lead

Study Sites (1)

Universitätsklinikum Erlangen

Erlangen, D-91054, Germany

Location

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Arnd Dörfler, Prof. Dr. med.

  Universitätsklinikum Erlangen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2019
• First Posted: April 18, 2019
• Study Start: April 10, 2019
• Primary Completion: June 9, 2023
• Study Completion (Estimated): December 30, 2027
• Last Updated: January 8, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)