Clinical trial NCT03920358: FRED/ FRED Jr/ FRED X Intracranial Aneurysm Treatment Study
Official title: FRED/ FRED Jr/ FRED X Intracranial Aneurysm Treatment Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Intracranial Aneurysm
Lead sponsor: Microvention-Terumo, Inc.
Sponsor class: INDUSTRY
First posted: 2019-04-18
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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 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.

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, 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

Primary outcomes:
measure: Rate of complete aneurysm occlusion without associated stenosis of the parent artery (> 50%)
timeFrame: 12 months
measure: Morbidity Rate
timeFrame: 6 months
measure: Mortality Rate
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen
Study officials:
affiliation: Universitätsklinikum Erlangen
name: Arnd Dörfler, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: