Intracranial AneurysmFREDNCT06982781
FRED Retrospective Study of Intracranial Aneurysms Treatment
An observational study of Intracranial Aneurysm, run by Microvention-Terumo, Inc..
Trial summary
To evaluate the long-term safety and efficacy of Flow Re-Direction Endoluminal Device System (FRED) in the treatment of intracranial aneurysms in the post-market environment Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Intracranial Aneurysm
- What is being tested?
- Flow Re-Direction Endoluminal Device System(FRED)
- Type of treatment
- Medical device
- How many people
- 2,000 participants
- Where
- No sites listed yet
- Study dates
- May 2025to 6 May 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient who has implanted at least one observational device in China mainland
Who may be able to join
- People in China mainland who have been treated with FRED. The patients for whom clinical data are available
Who cannot join
- Patients who met the inclusion criteria at all time points were required to be included in the study. Therefore, no specific exclusion criteria were set.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Retrospective Post-Market Clinical Study of the Flow Re-Direction Endoluminal Device System in the Treatment of Intracranial Aneurysms
To evaluate the long-term safety and efficacy of Flow Re-Direction Endoluminal Device System (FRED) in the treatment of intracranial aneurysms in the post-market environment
Read the detailed description
Study Objective: To evaluate the long-term safety and efficacy of Flow Re-Direction Endoluminal Device System (FRED) in the treatment of intracranial aneurysms in the post-market.
Study Design: Post-market, retrospective, multi-center, observational clinical study Study Population: Patient who has implanted at least one observational device in China mainland.
- Conditions
- Intracranial Aneurysm
- Being tested
- Flow Re-Direction Endoluminal Device System(FRED)
- Keywords
- Intracranial Aneurysms
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flow Re-Direction Endoluminal Device System(FRED)Device
Flow Diverter (FD) devices are developed based on reconstructing the parent artery's lumen. FDs are designed with a denser mesh compared to conventional intracranial stents. By covering the aneurysm neck, these stents redirect blood flow away from the aneurysm, promoting intra-aneurysmal flow stagnation and subsequent thrombosis formation. Currently, FDs are primarily used for the treatment of wide-neck aneurysms.
What is being measured
The primary outcome is the main question the study is designed to answer.
O'Kelly-Marotta, OKM grade (Imaging Evaluation of a Target Aneurysm)
Based on the evaluation of imaging results, the treatment of aneurysms was classified according to the following criteria. Digital Subtraction Angiography (DSA), Magnetic Resonance Angiography (MRA), or Computed Tomography Angiography (CTA) are acceptable, and it is recommended base CTA. The purpose of imaging follow-up information collection is to observe the effect of on the long-term closure of the aneurysm after treatment. Complete closure of the aneurysm would be associated with increased safety.
Measured: 6 month, 1 year
Raymond-Roy Grade (Adequate Occlusion Rate of Target Aneurysm)
Adequate Occlusion is defined as Raymond-Roy Grade I or Grade II on imaging evaluation of the target aneurysm.
Measured: 6 month, 1 year
Technical Success rate
The technical success rate refers to the proportion of technically successful patients in the total number of patients. Technical success is defined as successful stent placement and meet following criteria: Stent fully cover the aneurysm neck; Good wall apposition; Perfusion of the parent artery; Retention of contrast agent within the aneurysm;
Measured: Immediate post-procedure
Re-sheathing performance
During procedure, the observational device can be retrieved / re-sheathed into the microcatheter and re-deployed at the desired target location or removed completely from the patient. But it must not be re-deployed more than three times. Re-sheath performance refers to the retrieving and re-deploying of observational device recorded during the procedure. Information such as the number of recoveries and the number of re-sheathings, the success rate of re-opening and other information are recorded to evaluate the re-sheath performance of the observational device.
Measured: Immediate post-procedure
Modified Rankin Scale (mRS)
The modified Rankin (mRS) score was used to evaluate the improvement of neurological function. The modified Rankin score assesses the ability to live independently in patients with Neurological disease [6]. There are 7 levels of this score, 0 points represent no symptoms of disability, higher scores mean worse prognosis of patients, and 6 points represent death, See the table below for detailed scores.
Measured: 6 month, 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study startMay 2025 (estimated)
- Primary completion6 May 2027 (estimated)
- Study completion6 May 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
- Retrospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Microvention-Terumo, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tianxiao Li, Principal investigator, Henan Provincial People's HospitalSheng Guan, Principal investigator, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06982781
- Sponsor's protocol ID
- CL1106094
- Acronym
- FRED
- Status last verified
- May 2025
- First submitted
- 29 Apr 2025
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Post-Market Clinical Study of the Flow Re-Direction Endoluminal Device System in the Treatment of Intracranial Aneurysms
- ClinicalTrials.gov ID
- NCT06982781
- Acronym / sponsor ID
- FRED / CL1106094
- Conditions
- Intracranial Aneurysm
- Keywords
- Intracranial Aneurysms
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Microvention-Terumo, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2025 (estimated)
- Primary completion
- 6 May 2027 (estimated)
- Study completion
- 6 May 2027 (estimated)
- First posted
- 21 May 2025 (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.
To evaluate the long-term safety and efficacy of Flow Re-Direction Endoluminal Device System (FRED) in the treatment of intracranial aneurysms in the post-market environment
Detailed description
Study Objective: To evaluate the long-term safety and efficacy of Flow Re-Direction Endoluminal Device System (FRED) in the treatment of intracranial aneurysms in the post-market.
Study Design: Post-market, retrospective, multi-center, observational clinical study Study Population: Patient who has implanted at least one observational device in China mainland.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient who has implanted at least one observational device in China mainland
Key inclusion criteria (1 listed)
- People in China mainland who have been treated with FRED. The patients for whom clinical data are available
Key exclusion criteria (1 listed)
- Patients who met the inclusion criteria at all time points were required to be included in the study. Therefore, no specific exclusion criteria were set.
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 |
|---|---|---|
| Flow Re-Direction Endoluminal Device System(FRED)Flow Diverter (FD) devices are developed based on reconstructing the parent artery's lumen. FDs are designed with a denser mesh compared to conventional intracranial stents. By covering the aneurysm neck, these stents redirect blood flow away from the aneurysm, promoting intra-aneurysmal flow stagnation and subsequent thrombosis formation. Currently, FDs are primarily used for the treatment of wide-neck aneurysms. | Device | – |
Primary outcome
O'Kelly-Marotta, OKM grade (Imaging Evaluation of a Target Aneurysm)
Time frame: 6 month, 1 year
Based on the evaluation of imaging results, the treatment of aneurysms was classified according to the following criteria. Digital Subtraction Angiography (DSA), Magnetic Resonance Angiography (MRA), or Computed Tomography Angiography (CTA) are acceptable, and it is recommended base CTA. The purpose of imaging follow-up information collection is to observe the effect of on the long-term closure of the aneurysm after treatment. Complete closure of the aneurysm would be associated with increased safety.
Raymond-Roy Grade (Adequate Occlusion Rate of Target Aneurysm)
Time frame: 6 month, 1 year
Adequate Occlusion is defined as Raymond-Roy Grade I or Grade II on imaging evaluation of the target aneurysm.
Technical Success rate
Time frame: Immediate post-procedure
The technical success rate refers to the proportion of technically successful patients in the total number of patients. Technical success is defined as successful stent placement and meet following criteria: Stent fully cover the aneurysm neck; Good wall apposition; Perfusion of the parent artery; Retention of contrast agent within the aneurysm;
Re-sheathing performance
Time frame: Immediate post-procedure
During procedure, the observational device can be retrieved / re-sheathed into the microcatheter and re-deployed at the desired target location or removed completely from the patient. But it must not be re-deployed more than three times. Re-sheath performance refers to the retrieving and re-deploying of observational device recorded during the procedure. Information such as the number of recoveries and the number of re-sheathings, the success rate of re-opening and other information are recorded to evaluate the re-sheath performance of the observational device.
Modified Rankin Scale (mRS)
Time frame: 6 month, 1year
The modified Rankin (mRS) score was used to evaluate the improvement of neurological function. The modified Rankin score assesses the ability to live independently in patients with Neurological disease [6]. There are 7 levels of this score, 0 points represent no symptoms of disability, higher scores mean worse prognosis of patients, and 6 points represent death, See the table below for detailed scores.
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 21 May 2025.
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.
Tianxiao Li principal investigator
Henan Provincial People's Hospital
Sheng Guan principal investigator
The First Affiliated Hospital of Zhengzhou University
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Aneurysm, 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 1 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: opening soon, as of the sponsor's last update on 21 May 2025. 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?
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?
Contact Brook Li (86 138 918 55337, brook.li@microvention.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
O'Kelly-Marotta, OKM grade (Imaging Evaluation of a Target Aneurysm) (time frame: 6 month, 1 year). The study lists 5 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 21 May 2025.