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FRED/FRED Jr Intracranial Aneurysm Treatment Study (FRITS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03920358
Recruitment Status : Recruiting
First Posted : April 18, 2019
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment
Intracranial Aneurysm Device: FRED and FRED Jr

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.

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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 10, 2019
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : September 30, 2024

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: FRED and FRED Jr
    Subjects aged ≥ 18 requiring treatment for an unruptured or recanalized intracranial aneurysm
    Other Name: Flow Re-Direction Endoluminal Device


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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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.
Criteria

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 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 or in addition to FRED/FRED Jr is planned

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03920358


Contacts
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Contact: Laurence Bousquet, PhD +33139217746 laurence.bousquet@microvention.com
Contact: Patricia Boyer +33139217746 patricia.boyer@microvention.com

Locations
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Germany
Universitätsklinikum Erlangen Recruiting
Erlangen, Germany, D-91054
Contact: Arnd Dörfler, Prof. Dr. med.         
Sponsors and Collaborators
Microvention-Terumo, Inc.
Investigators
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Principal Investigator: Arnd Dörfler, Prof. Dr. med. Universitätsklinikum Erlangen
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Responsible Party: Microvention-Terumo, Inc.
ClinicalTrials.gov Identifier: NCT03920358    
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 Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Intracranial Aneurysm
Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases