Intracranial AneurysmNCT04315168
FRED and FRED JR Devices for Intracranial Aneurysm Treatment
An observational study of Intracranial Aneurysm, run by Microvention-Terumo, Inc. at 1 site in France.
Trial summary
A French, multicenter, prospective, observational, "real-world" assessment of the safety and efficacy of FRED and FRED Jr devices in the treatment of intracranial aneurysms Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Intracranial Aneurysm
- What is being tested?
- FRED and FRED JR
- Type of treatment
- Medical device
- How many people
- 135 participants
- Where
- 1 siteFrance
- Study dates
- 12 Jun 2020to 31 Dec 2023
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patient with an intracranial aneurysm treated with the FRED or FRED JR Device
Who may be able to join
- Patient with an intracranial aneurysm for which an endovascular treatment is indicated with the device FRED or FRED JR
- Patient or patient's legally authorized representative has been informed about the study and does not oppose the collection of his/her personal data
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Safety and Efficacy of the FRED and FRED JR Devices for Intracranial Aneurysm Treatment
A French, multicenter, prospective, observational, "real-world" assessment of the safety and efficacy of FRED and FRED Jr devices in the treatment of intracranial aneurysms
Read the detailed description
Post Market Clinical Follow-up. Multicenter observational study. Treatment and follow-up far at least 12 months as per standard of care.
Sample Size: 138 patients.
- Conditions
- Intracranial Aneurysm
- Being tested
- FRED and FRED JR
- Keywords
- aneurysm, endovascular, flow-diverter
- Medical subject headings
- Intracranial Aneurysm, Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FRED and FRED JRDevice
Also called Flow Re-Direction Endoluminal Device
Intracranial aneurysm treatment
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality Rate
Percentage of patients with neurological death
Measured: 1 year
Morbidity Rate
Percentage of patients with major ipsilateral stroke
Measured: 1 year
Secondary outcomes (4)
modified Rankin Score
worsening mRS (scale from 0 to 6 : 0= No symptom, 6= Death)
Measured: 1 year
Complete aneurysm occlusion rate
Measured by the Raymond Scale
Measured: 1 year
Retreatment Rate
Rate and description of aneurysm retreated or planned for retreatment
Measured: 1 year
Patient description
Description of the population of patients treated with FRED and FRED JR in France
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2020
- Study start12 Jun 2020
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
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
- 135 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Microvention-Terumo, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Laurent Pierot, Prof., Principal investigator, Hôpital Maison Blanche, Reims, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04315168
- Sponsor's protocol ID
- FRED-EPI
- Status last verified
- Jan 2024
- First submitted
- 17 Mar 2020
- Last updated
- 23 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Safety and Efficacy of the FRED and FRED JR Devices for Intracranial Aneurysm Treatment
- ClinicalTrials.gov ID
- NCT04315168
- Acronym / sponsor ID
- FRED-EPI
- Conditions
- Intracranial Aneurysm
- Keywords
- aneurysm, endovascular, flow-diverter
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Microvention-Terumo, Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Jun 2020 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 19 Mar 2020 (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 French, multicenter, prospective, observational, "real-world" assessment of the safety and efficacy of FRED and FRED Jr devices in the treatment of intracranial aneurysms
Detailed description
Post Market Clinical Follow-up. Multicenter observational study. Treatment and follow-up far at least 12 months as per standard of care.
Sample Size: 138 patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patient with an intracranial aneurysm treated with the FRED or FRED JR Device
Key inclusion criteria (2 listed)
- Patient with an intracranial aneurysm for which an endovascular treatment is indicated with the device FRED or FRED JR
- Patient or patient's legally authorized representative has been informed about the study and does not oppose the collection of his/her personal data
Key exclusion criteria (1 listed)
- None
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 and FRED JRAlso: Flow Re-Direction Endoluminal DeviceIntracranial aneurysm treatment | Device | – |
Primary outcome
Mortality Rate
Time frame: 1 year
Percentage of patients with neurological death
Morbidity Rate
Time frame: 1 year
Percentage of patients with major ipsilateral stroke
4 secondary outcomes
modified Rankin Score
Time frame: 1 year
Complete aneurysm occlusion rate
Time frame: 1 year
Retreatment Rate
Time frame: 1 year
Patient description
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
- Individual participant dataSharing planned: No
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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.
Laurent Pierot, Prof. principal investigator
Hôpital Maison Blanche, Reims, France
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 France.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 23 Jan 2024. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mortality Rate (time frame: 1 year). The study lists 2 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 23 Jan 2024.