Intracranial AneurysmFRITSNCT03920358
FRED/ FRED Jr/ FRED X Intracranial Aneurysm Treatment Study
An observational study of Intracranial Aneurysm, run by Microvention-Terumo, Inc. at 1 site in Germany.
Trial summary
A prospective, multicenter, observational evaluation of the safety and efficacy of the FRED® device in the treatment of intracranial aneurysms Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracranial Aneurysm
- What is being tested?
- FRED, FRED Jr and FRED X
- Type of treatment
- Medical device
- How many people
- 156 participants
- Where
- 1 siteGermany
- Study dates
- 10 Apr 2019to 30 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patient older than 18 years old
- 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
- Patient with a modified Rankin Scale (mRS) ≤ 2
- Patient has received information about data collection and has signed and dated an Informed Consent Form
Who cannot join
- Patient has suffered from an ICH within the 30 days prior to the procedure.
- The aneurysm to be treated is associated with a cAVM
- The aneurysm to be treated is in the posterior circulation
- The aneurysm to be treated has a stenosis of its parent artery >50%
- Patient has another aneurysm previously treated with a stent or a flow diverter
- on the same parent vessel at any time
Show all 13Show fewer
- on a different parent vessel, less than 3 months prior to the procedure (previously-implanted stents in the non-index proximal carotid are acceptable)
- Patient with whom anticoagulant, antiplatelet or thrombolytic drugs are contra-indicated or test performed regarding AP medication administered is not efficient for the patient
- Patient with known hypersensitivity to contrast products or nickel titanium, not treatable
- Pregnancy or child breastfeeding
- Patient unable or unlikely to complete required follow up
- Patient has severe or fatal comorbidity or a life expectancy of less than 1 year
- Treatment with a flow diverter other than FRED/ FRED Jr/ FRED X or in addition to FRED/ FRED Jr/ FRED X is planned
Trial locations and contacts
1 site in 1 country.
About this study
A prospective, multicenter, observational evaluation of the safety and efficacy of the FRED® device in the treatment of intracranial aneurysms
Read the 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.
- Conditions
- Intracranial Aneurysm
- Being tested
- FRED, FRED Jr and FRED X
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FRED, FRED Jr and FRED XDevice
Also called Flow Re-Direction Endoluminal Device
Subjects aged ≥ 18 requiring treatment for an unruptured or recanalized intracranial aneurysm
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of complete aneurysm occlusion without associated stenosis of the parent artery (> 50%)
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
Measured: 12 months
Morbidity Rate
Patients with mRS>2
Measured: 6 months
Mortality Rate
Deaths within 6 months after treatment
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2019
- Study start10 Apr 2019
- Primary completion9 Jun 2023
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial AneurysmStudies of the same condition, open and under way.
- More trials run by Microvention-Terumo, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Microvention-Terumo, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Arnd Dörfler, Prof. Dr. med., Principal investigator, University of Erlangen-Nürnberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03920358
- Sponsor's protocol ID
- CIP EMEA 18-01
- Acronym
- FRITS
- Status last verified
- Jan 2025
- First submitted
- 15 Apr 2019
- Last updated
- 8 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FRED/ FRED Jr/ FRED X Intracranial Aneurysm Treatment Study
- ClinicalTrials.gov ID
- NCT03920358
- Acronym / sponsor ID
- FRITS / CIP EMEA 18-01
- Conditions
- Intracranial Aneurysm
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Microvention-Terumo, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Apr 2019 (actual)
- Primary completion
- 9 Jun 2023 (actual)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 18 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- Patient older than 18 years old
- Patient harboring a non-acutely ruptured intracranial aneurysm within the last 30 days of presentation:
- Patient with a modified Rankin Scale (mRS) ≤ 2
- Patient has received information about data collection and has signed and dated an Informed Consent Form
Key exclusion criteria (13 listed)
- Patient has suffered from an ICH within the 30 days prior to the procedure.
- The aneurysm to be treated is associated with a cAVM
- The aneurysm to be treated is in the posterior circulation
- The aneurysm to be treated has a stenosis of its parent artery >50%
- Patient has another aneurysm previously treated with a stent or a flow diverter
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FRED, FRED Jr and FRED XAlso: Flow Re-Direction Endoluminal DeviceSubjects aged ≥ 18 requiring treatment for an unruptured or recanalized intracranial aneurysm | Device | – |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2025.
- Individual participant dataSharing planned: No
Related trials for Intracranial Aneurysm
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
RecruitingObservational study
Determining the Clinical Impact and Prevalence of Hemorrhagic Subtypes in Perimesencephalic Subarachnoid Hemorrhage
Subarachnoid Hemorrhage, Spontaneous, Subarachnoid Hemorrhage, Aneurysmal
Not yet recruitingPhase 1/2
Induced Suppression of Platelet Activity in Aneurysmal Subarachnoid Hemorrhage Management-2 (iSPASM-2)
Aneurysmal Subarachnoid Hemorrhage
RecruitingObservational study
A Study of Choydar Flow-Directed Mesh Stent in the Treatment of Unruptured Intracranial Aneurysms
Intracranial Aneurysm
Not yet recruiting
Effect of Bilateral Greater Occipital Nerve Block on Headache After Intracranial Aneurysm Coiling
Intracranial Aneurysm, Postoperative Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arnd Dörfler, Prof. Dr. med. principal investigator
University of Erlangen-Nürnberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Aneurysm, run by Microvention-Terumo, Inc. at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of complete aneurysm occlusion without associated stenosis of the parent artery (> 50%) (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2025.