FRED
A Retrospective Post-Market Clinical Study of the Flow Re-Direction Endoluminal Device System in the Treatment of Intracranial Aneurysms
Sponsor study identifier
observational
2,000
0 countries
N/A
Study Start
May 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
May 6, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
May 6, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 6, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 29, 2025
Actual (reported)May 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
May 21, 2025
Actual (reported)May 6, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
May 6, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
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.
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;
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.
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.
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Patient who has implanted at least one observational device in China mainland
Contact the study team to confirm eligibility.
Tianxiao Li
Henan Provincial People's Hospital
Sheng Guan
The First Affiliated Hospital of Zhengzhou University
First Submitted
April 29, 2025
First Posted
May 21, 2025
Study Start
May 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
May 6, 2027
EstimatedSafety and Efficacy Analysis of FRED™/FRED™Jr Embolic Device in Aneurysm Treatment
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.
6 month, 1year
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
May 6, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
May 21, 2025
Record last verified: 2025-05
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Source: ClinicalTrials.gov.
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