Clinical trial NCT03423290: Safety and Efficacy Analysis of FRED™/FRED™Jr Embolic Device in Aneurysm Treatment
Official title: Safety and Efficacy Analysis of FRED™/FRED™Jr Embolic Device in Aneurysm Treatment, a UK, Multi-center, Single Arm, Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intracranial Aneurysm
Lead sponsor: Microvention-Terumo, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Clinact
First posted: 2018-02-06
Enrollment: 61
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 aged a minimum of 18 years with an unruptured or recanalized intracranial aneurysm in whom endovascular treatment has been determined the appropriate treatment

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 done as per standard of care.

The purpose of this study is to demonstrate that use of the FRED/FRED Jr Embolic device in intracranial aneurysm treatment is safe and effective when assessed at 1, 6 and 12 month post procedure.

100 patients will be enrolled over an 18-month recruitment period. All patients will be followed for 12 months.

Eligibility criteria: Inclusion Criteria:

1. Patient older than 18 years old
2. Patient harboring an unruptured intracranial aneurysm:

   * for which endovascular treatment is indicated
   * for which use of FRED or FRED Jr has been deemed appropriate
   * being the only one to require treatment over the period of the study
   * 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 or patient's legally authorized representative has received information about data collection and has signed and dated an Informed Consent Form

Exclusion Criteria:

1. Patient has suffered an ICH within the 30 days prior to the procedure.
2. The aneurysm to be treated is associated with an cAVM
3. The aneurysm to be treated is a dissecting or blister-like aneurysm
4. The aneurysm to be treated or any other aneurysm is in the posterior circulation
5. The aneurysm to be treated has a stenosis of its parent artery
6. Patient has another aneurysm previously treated with a stent or a flow diverter

   * on the same parent vessel at any time (except in the case of the proximal carotid if the treatment occurred more than 3 months prior to the procedure)
   * on a different parent vessel, less than 3 months prior to the procedure
7. Patient has another aneurysm requiring treatment within the study period
8. Patient with a known allergy to antiplatelet, to heparin, to contrast products or nickel titanium
9. Patient with a contra-indication to antiplatelet or heparin
10. Pregnancy or child breastfeeding
11. Patient unable or unlikely to complete required follow up
12. Patient has severe or fatal comorbidity or a life expectancy of less than 1 year
13. Treatment with a flow diverter other than FRED/FRED Jr or in addition to FRED/FRED Jr is planned.

Primary outcomes:
measure: Complete aneurysm occlusion without ˃ 50% parent artery stenosis
timeFrame: 6 months
measure: Morbidity rate
timeFrame: 6 months
measure: Mortality rate
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: University Hospital Birmingham
city: Brighton
country: United Kingdom
facility: Brighton & Sussex Universitys Hospitals
city: Edinburgh
country: United Kingdom
facility: Western General Hospital - NHS Lothian
city: Liverpool
country: United Kingdom
facility: The Walton Centre NHS Foundation Trust
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
city: Newcastle Upon Tyne
country: United Kingdom
facility: The Newcastle upon Tyne Hospitals NHS Foundation Trust
city: Stoke-on-Trent
country: United Kingdom
facility: University Hospitals of North Midlands NHS Trust
Study officials:
affiliation: Imperial College Healthcare NHS Trust
name: Kyriakos Lobotesis, MD
role: PRINCIPAL_INVESTIGATOR
References: