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NCT Number: NCT06982781

FRED Retrospective Study of Intracranial Aneurysms Treatment

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

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Key information

Conditions

Intracranial Aneurysm Aneurysm Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Intracranial Arterial Diseases Nervous System Diseases Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • People in China mainland who have been treated with FRED. The patients for whom clinical data are available

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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;

  4. 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.

  5. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Brook Li

CONTACT

[email protected]

86 138 918 55337

Sponsors and collaborators

Lead sponsor

Microvention-Terumo, Inc.

Industry

Registry information

Official study title

A Retrospective Post-Market Clinical Study of the Flow Re-Direction Endoluminal Device System in the Treatment of Intracranial Aneurysms

Acronym: FRED

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 21, 2025
Registry last updated
May 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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