Intracranial AneurysmNCT03423290
Safety and Efficacy Analysis of FRED™/FRED™Jr Embolic Device in Aneurysm Treatment
An observational study of Intracranial Aneurysm, run by Microvention-Terumo, Inc. at 7 sites in United Kingdom.
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 and FRED Jr
- Type of treatment
- Medical device
- How many people
- 61 participants
- Where
- 7 sitesUnited Kingdom
- Study dates
- 23 Nov 2017to 26 Jan 2022
- 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 older than 18 years old
- 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
- Patient with a modified Rankin Scale (mRS) ≤ 2
- Patient or patient's legally authorized representative has received information about data collection and has signed and dated an Informed Consent Form
Who cannot join
- Patient has suffered an ICH within the 30 days prior to the procedure.
- The aneurysm to be treated is associated with an cAVM
- The aneurysm to be treated is a dissecting or blister-like aneurysm
- The aneurysm to be treated or any other aneurysm is in the posterior circulation
- The aneurysm to be treated has a stenosis of its parent artery
- Patient has another aneurysm previously treated with a stent or a flow diverter
Show all 15Show fewer
- 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
- Patient has another aneurysm requiring treatment within the study period
- Patient with a known allergy to antiplatelet, to heparin, to contrast products or nickel titanium
- Patient with a contra-indication to antiplatelet or heparin
- 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 or in addition to FRED/FRED Jr is planned.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United Kingdom7 sites
University Hospital Birmingham
Birmingham, B15 2TH
Brighton & Sussex Universitys Hospitals
Brighton, BN2 5BE
Western General Hospital - NHS Lothian
Edinburgh, EH4 2XU
The Walton Centre NHS Foundation Trust
Liverpool, L97 LJ
Imperial College Healthcare NHS Trust
London, W6 8RF
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, NE7 7DN
University Hospitals of North Midlands NHS Trust
Stoke-on-Trent, ST4 6QG
About this study
Official title: Safety and Efficacy Analysis of FRED™/FRED™Jr Embolic Device in Aneurysm Treatment, a UK, Multi-center, Single Arm, Prospective Observational 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 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.
- Conditions
- Intracranial Aneurysm
- Being tested
- FRED and FRED Jr
- 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 and FRED JrDevice
Flow Re-Direction Endoluminal Device
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete aneurysm occlusion without ˃ 50% parent artery stenosis
Evaluated by Corelab
Measured: 6 months
Morbidity rate
patients with mRS>2
Measured: 6 months
Mortality rate
patients with mRS=6
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 posted6 Feb 2018
- Study start23 Nov 2017
- Primary completion30 Sep 2021
- Study completion26 Jan 2022
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
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Microvention-Terumo, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clinact
- Responsible party
- Sponsor
- Investigators
- Kyriakos Lobotesis, MD, Principal investigator, Imperial College Healthcare NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03423290
- Sponsor's protocol ID
- FRED-UK Registry
- Status last verified
- Apr 2022
- First submitted
- 31 Jan 2018
- Last updated
- 29 Apr 2022
- 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 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Analysis of FRED™/FRED™Jr Embolic Device in Aneurysm Treatment, a UK, Multi-center, Single Arm, Prospective Observational Study
- ClinicalTrials.gov ID
- NCT03423290
- Acronym / sponsor ID
- FRED-UK Registry
- Conditions
- Intracranial Aneurysm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Microvention-Terumo, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Clinact
- Study start
- 23 Nov 2017 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 26 Jan 2022 (actual)
- First posted
- 6 Feb 2018 (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 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.
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 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 (8 listed)
- Patient older than 18 years old
- Patient harboring an unruptured intracranial aneurysm:
- Patient with a modified Rankin Scale (mRS) ≤ 2
- Patient or patient's legally authorized representative has received information about data collection and has signed and dated an Informed Consent Form
Key exclusion criteria (15 listed)
- Patient has suffered an ICH within the 30 days prior to the procedure.
- The aneurysm to be treated is associated with an cAVM
- The aneurysm to be treated is a dissecting or blister-like aneurysm
- The aneurysm to be treated or any other aneurysm is in the posterior circulation
- The aneurysm to be treated has a stenosis of its parent artery
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 JrFlow Re-Direction Endoluminal Device | Device | – |
Primary outcome
Complete aneurysm occlusion without ˃ 50% parent artery stenosis
Time frame: 6 months
Evaluated by Corelab
Morbidity rate
Time frame: 6 months
patients with mRS>2
Mortality rate
Time frame: 6 months
patients with mRS=6
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 29 Apr 2022.
- 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.
Kyriakos Lobotesis, MD principal investigator
Imperial College Healthcare NHS Trust
7 sites 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 7 sites in United Kingdom.
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 8 inclusion and 15 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 29 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United Kingdom. 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?
Complete 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?
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 29 Apr 2022.