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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/22/2021.

FRED/FRED Jr Intracranial Aneurysm Treatment Study

Clinicaltrials.gov identifier NCT03920358

Recruitment Status Recruiting

First Posted April 18, 2019

Last update posted April 18, 2019

Study Description

Brief summary:

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

  • Condition or Disease:Intracranial Aneurysm
  • Intervention/Treatment: Device: FRED and FRED Jr
  • Phase: N/A
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 FREDTM/FREDTM Jr 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 Design
  • Study Type: Observational
  • Estimated Enrollment: 150 participants
  • Observational Model: Cohort
  • Time Perspective: Prospective
  • Official Title: FRED/FRED Jr Intracranial Aneurysm Treatment Study
  • Actual Study Start Date: April 2019
  • Estimated Primary Completion Date: April 2021
  • Estimated Study Completion Date: September 2024
Outcome Measures
  • Primary Outcome Measures: 1. Rate of complete aneurysm occlusion without associated stenosis of the parent artery (> 50%) [ Time Frame: 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
  • 2. Morbidity Rate [ Time Frame: 6 months ]
    Patients with mRS>2
  • 3. Mortality Rate [ Time Frame: 6 months ]
    Deaths within 6 months after treatment
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
  • 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 will be enrolled after having signed an informed consent form.

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 or FRED Jr 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

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 or in addition to FRED/FRED Jr
is planned

Contacts and Locations

Contact: Laurence Bousquet, PhD +33139217746 laurence.bousquet@microvention.com

Contact: Patricia Boyer +33139217746 patricia.boyer@microvention.com


Universitätsklinikum Erlangen

Sponsors and Collaborators

Microvention-Terumo, Inc.


Principal Investigator: Arnd Dörfler, Prof. Dr. med. Universitätsklinikum Erlangen

More Information
  • Responsible Party: Microvention-Terumo, Inc.
  • ClinicalTrials.gov Identifier: NCT03920358 History of Changes
  • Other Study ID Numbers: CIP EMEA 18-01
  • First Posted: April 18, 2019 Key Record Dates
  • Last Update Posted: April 18, 2019
  • Last Verified: April 2019
  • Individual Participant
    Data (IPD) Sharing
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Intracranial Aneurysm Aneurysm