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出境医 / 临床实验 / FRED/FRED Jr Intracranial Aneurysm Treatment Study (FRITS)

FRED/FRED Jr Intracranial Aneurysm Treatment Study (FRITS)

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 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.

Study Design
Layout table for study information
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
Arms and Interventions
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
Contacts and Locations
Tracking Information
First Submitted Date April 15, 2019
First Posted Date April 18, 2019
Last Update Posted Date April 18, 2019
Actual Study Start Date April 10, 2019
Estimated Primary Completion Date April 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 17, 2019)
  • 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
  • Morbidity Rate [ Time Frame: 6 months ]
    Patients with mRS>2
  • Mortality Rate [ Time Frame: 6 months ]
    Deaths within 6 months after treatment
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title FRED/FRED Jr Intracranial Aneurysm Treatment Study
Official Title FRED/FRED Jr Intracranial Aneurysm Treatment Study
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 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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Intracranial Aneurysm
Intervention Device: FRED and FRED Jr
Subjects aged ≥ 18 requiring treatment for an unruptured or recanalized intracranial aneurysm
Other Name: Flow Re-Direction Endoluminal Device
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 17, 2019)
150
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 30, 2024
Estimated Primary Completion Date April 30, 2021   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Laurence Bousquet, PhD +33139217746 laurence.bousquet@microvention.com
Contact: Patricia Boyer +33139217746 patricia.boyer@microvention.com
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT03920358
Other Study ID Numbers CIP EMEA 18-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Microvention-Terumo, Inc.
Study Sponsor Microvention-Terumo, Inc.
Collaborators Not Provided
Investigators
Principal Investigator: Arnd Dörfler, Prof. Dr. med. Universitätsklinikum Erlangen
PRS Account Microvention-Terumo, Inc.
Verification Date April 2019