🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Contributor sign in
Latest
Clinical Trials in Germany / NCT03920358
Active, not recruiting Observational

FRED/ FRED Jr/ FRED X Intracranial Aneurysm Treatment Study

NCT03920358 · tracked via the Priya Life Science Germany tracker
Phase
Observational
Started
2019-04-10
Last updated
2025-01-08

Condition(s) studied

Intracranial Aneurysm

Investigational drug(s) / intervention(s)

FRED, FRED Jr and FRED X

FRED, FRED Jr and FRED X: Subjects aged ≥ 18 requiring treatment for an unruptured or recanalized intracranial aneurysm

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Universitätsklinikum Erlangen Erlangen Germany

More Microvention-Terumo, Inc. trials in Germany

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03920358 on ClinicalTrials.gov ↗ ← All trials in Germany