FRED Retrospective Study of Intracranial Aneurysms Treatment

NCT06982781 | Not Yet Recruiting FDA Device

• 1 other identifier: CL1106094
• Study Type: observational
• Target: 2,000
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Intracranial Aneurysm

Keywords

Intracranial Aneurysms

Outcome Measures

Primary Outcomes (5)

• 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.

  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

Interventions

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.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient who has implanted at least one observational device in China mainland

You may qualify if:

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

Sponsors & Collaborators

• Microvention-Terumo, Inc.: lead

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

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

Study Officials

• Tianxiao Li

  Henan Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

• Sheng Guan

  The First Affiliated Hospital of Zhengzhou University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brook Li

CONTACT

86 138 918 55337; brook.li@microvention.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2025
• First Posted: May 21, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): May 6, 2027
• Study Completion (Estimated): May 6, 2027
• Last Updated: May 21, 2025

Record last verified: 2025-05