Intracranial AneurysmsSAFENCT02921698
Safety and Efficacy Analysis of FRED® Embolic Device in Aneurysm Treatment
An observational study of Intracranial Aneurysms, run by Microvention-Terumo, Inc..
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 Aneurysms
- What is being tested?
- FRED®
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jul 2014to Dec 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patient is aged ≥18 years
- Patient has an unruptured or recanalized intracranial aneurysm :
- for which an endovascular treatment has been determined appropriate
- that can not be treated by standard techniques (coiling with or without remodeling)
- and for which the FRED® Flow Diverter has been determined an appropriate treatment
- Patient or patient's legally authorized representative has been informed about the confidentiality of the study and agrees to the collection of his/her personal data
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- Patient presents with an mRS score between 0 and 2
- Patients who have already been treated with a stent or a flow diverter for another aneurysm may be included if:
- the previous treatment was more than three months prior to enrollment in this study
- the aneurysm to be treated for this study is a new aneurysm located on a different parent vessel unless the stent already in place is implanted on the proximal carotid artery.
Who cannot join
- Patient has a known allergy to antiplatelet therapy, heparin and/or contrast medium
- Patient has contraindication to antiplatelet therapy and/or heparin
- Patient is pregnant and/or breastfeeding
- Patient may not benefit from imaging and clinical monitoring
- Patient has a medical or surgical co-morbidities limiting his/her life expectancy to less than 1 year
- Patient will be treated with a flow diverter other than FRED®
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- Patient had an intracranial hemorrhage within the 30 days preceding treatment
- Patient has an aneurysm(s) with one or more of the following characteristics:
- associated with an arteriovenous malformation
- dissecting or ""blister-like""
- multiple (unless only one aneurysm requires treatment)
- located in the posterior circulation
- treated with a stent or a flow diverter on the same parent vessel (excluding proximal carotid artery) or in the 3 months prior to inclusion
- Patient has stenosis of the aneurysm parent artery.
About this study
A prospective, multicenter, observational evaluation of the safety and efficacy of the FRED® device in the treatment of intracranial aneurysms.
- Conditions
- Intracranial Aneurysms
- Being tested
- FRED®
- 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®Device
Flow Re-Direction Endoluminal Device
| Study group | Role | What they receive |
|---|---|---|
| FRED® | Not described Receives: Device: FRED® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aneurysm occlusion without ˃ 50% parent artery stenosis
Measured: 6 months
Morbidity rate
Measured: 6 months
Mortality rate
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 posted3 Oct 2016 (estimated)
- Study startJul 2014
- Primary completionFeb 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Intracranial AneurysmsStudies 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
- 100 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, CHU Reims; Reims, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02921698
- Sponsor's protocol ID
- SAFE
- Acronym
- SAFE
- Status last verified
- Aug 2017
- First submitted
- 27 Sep 2016
- Last updated
- 17 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Pierot L, Spelle L, Berge J, Januel AC, Herbreteau D, Aggour M, Piotin M, Biondi A, Barreau X, Mounayer C, Papagiannaki C, Lejeune JP, Gauvrit JY, Derelle AL, Chabert E, Costalat V. SAFE study (Safety and efficacy Analysis of FRED Embolic device in aneurysm treatment): 1-year clinical and anatomical results. J Neurointerv Surg. 2019 Feb;11(2):184-189. doi: 10.1136/neurintsurg-2018-014261. Epub 2018 Oct 8.
PubMed 30297539Pierot L, Spelle L, Berge J, Januel AC, Herbreteau D, Aggour M, Piotin M, Biondi A, Barreau X, Mounayer C, Papagiannaki C, Lejeune JP, Gauvrit JY, Costalat V. Feasibility, complications, morbidity, and mortality results at 6 months for aneurysm treatment with the Flow Re-Direction Endoluminal Device: report of SAFE study. J Neurointerv Surg. 2018 Aug;10(8):765-770. doi: 10.1136/neurintsurg-2017-013559. Epub 2018 Jan 19.
PubMed 29352057
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Analysis of FRED® Embolic Device in Aneurysm Treatment
- ClinicalTrials.gov ID
- NCT02921698
- Acronym / sponsor ID
- SAFE / SAFE
- Conditions
- Intracranial Aneurysms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Microvention-Terumo, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Feb 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 3 Oct 2016 (estimated)
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FRED® | – | Device: FRED® |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (10 listed)
- Patient is aged ≥18 years
- Patient has an unruptured or recanalized intracranial aneurysm :
- Patient or patient's legally authorized representative has been informed about the confidentiality of the study and agrees to the collection of his/her personal data
- Patient presents with an mRS score between 0 and 2
- Patients who have already been treated with a stent or a flow diverter for another aneurysm may be included if:
Key exclusion criteria (14 listed)
- Patient has a known allergy to antiplatelet therapy, heparin and/or contrast medium
- Patient has contraindication to antiplatelet therapy and/or heparin
- Patient is pregnant and/or breastfeeding
- Patient may not benefit from imaging and clinical monitoring
- Patient has a medical or surgical co-morbidities limiting his/her life expectancy to less than 1 year
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®Flow Re-Direction Endoluminal Device | Device | FRED® |
Primary outcome
Aneurysm occlusion without ˃ 50% parent artery stenosis
Time frame: 6 months
Morbidity rate
Time frame: 6 months
Mortality rate
Time frame: 6 months
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 17 May 2018.
- Derived from this study: PubMed 30297539Pierot L, Spelle L, Berge J, Januel AC, Herbreteau D, Aggour M, Piotin M, Biondi A, Barreau X, Mounayer C, Papagiannaki C, Lejeune JP, Gauvrit JY, Derelle AL, Chabert E, Costalat V. SAFE study (Safety and efficacy Analysis of FRED Embolic device in aneurysm treatment): 1-year clinical and anatomical results. J Neurointerv Surg. 2019 Feb;11(2):184-189. doi: 10.1136/neurintsurg-2018-014261. Epub 2018 Oct 8.
- Derived from this study: PubMed 29352057Pierot L, Spelle L, Berge J, Januel AC, Herbreteau D, Aggour M, Piotin M, Biondi A, Barreau X, Mounayer C, Papagiannaki C, Lejeune JP, Gauvrit JY, Costalat V. Feasibility, complications, morbidity, and mortality results at 6 months for aneurysm treatment with the Flow Re-Direction Endoluminal Device: report of SAFE study. J Neurointerv Surg. 2018 Aug;10(8):765-770. doi: 10.1136/neurintsurg-2017-013559. Epub 2018 Jan 19.
- 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
CHU Reims; Reims, France
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Aneurysms, run by Microvention-Terumo, Inc..
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 10 inclusion and 14 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 17 May 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Aneurysm occlusion without ˃ 50% parent artery stenosis (time frame: 6 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?
On the ClinicalTrials.gov record for NCT02921698, which also lists 2 linked publications.
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 17 May 2018.