Parent Artery Reconstruction for Cerebral Aneurysms Using a Novel Flow Diverter With Surface Modification

A Prospective, Multi-center, Single Arm Clinical Study to Evaluate the Safety and Effectiveness of the Flow Diverter Stent System in the Treatment of Cerebral Aneurysms

The primary objective of this trial is to evaluate the safety and efficacy of the cerebral flow diverter in the endovascular treatment of wide-necked cerebral aneurysms

Study Overview

• Status: Completed
• Conditions: Cerebral Aneurysm; Cerebral Aneurysm Unruptured
• Intervention / Treatment: Device: Cerebral flow diverter

Detailed Description

The investigation is a prospective, multi-center, single arm clinical study. The trial is anticipated to last from March 2023 to January 2025 with 143 subjects recruited in around 10 China centers. The population for this study is subjects with wide-necked intracranial aneurysms who are suitable candidates for flow diverter implantation. Patients fulfilling all of the inclusion criteria and none of the exclusion criteria will be enrolled after offering informed consent form. The study consists of six visits including preoperative screening, operation date, 7days or at discharge, 30 days, 180 days, and 1 year. The primary efficacy endpoint was complete aneurysm occlusion with parent artery stenosis ≤ 50% at one year post-procedure in the absence of additional treatments, while the primary safety endpoint was no major stroke in the treated artery territory or neurological death at one year post-procedure.

• Study Type: Interventional
• Enrollment (Actual): 143
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Xuanwu Hospital Capital Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age 18 years to 75 years, male or non-pregnant female.
2. Unruptured wide-necked cerebral aneurysms confirmed by preoperative imaging (Wide-necked is defined as width ≥ 4 mm or a dome-to-neck ratio < 2).
3. Parent vessel with a diameter range of 1.75-6.0 mm.
4. Those who voluntarily participate in the study and sign informed consent form.

Exclusion Criteria:

1. Subject with target aneurysms are blood blister-like aneurysms, pseudoaneurysms, arteriovenous malformation, moyamoya disease-related aneurysm, or multiple aneurysms that cannot be treated with a single stent.
2. Severe arteriosclerosis or tortuosity of intracranial artery, and the device is difficult to reach the target vessel.
3. Subject with target aneurysm previously treated with craniotomy or other endovascular interventional therapy.
4. Known sensitivity to antiplatelet medications, anticoagulant medications, radiographic contrast agents, anesthetic, nickel, platinum-tungsten alloy, platinum-iridium alloy, and poly-N-[Tris(hydroxymethyl)methyl] acrylamide (poly-NTMA).
5. Severe respiratory system, liver and kidney diseases (such as creatinine ≥ 3.0 mg/dL (except dialysis)) or blood coagulation disorders before operation.
6. Platelet count is less than 100×109/L, international normalized ratio (INR) is more than 1.5.
7. Hospitalized surgical treatment within the previous 30 days or planned within the next 180 days after operation.
8. Severe neurological deficit that renders the patient incapable of living independently (modified Rankin score ≥3).
9. The survival expectation is less than 1 year.
10. All subjects who are participating in other drug/medical device clinical trials and have not completed the programme requirements
11. Inapplicable for this study at the investigators' viewpoints.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cerebral flow diverter; The cerebral flow diverter in the endovascular treatment of wide-necked cerebral aneurysms	Device: Cerebral flow diverter; The surface-modified flow diverter is an intracranial implant designed to be placed in a parent artery so as to divert blood flow away from an aneurysm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete aneurysm occlusion without significant parent artery stenosis (≤50%) or retreatment at 1 year post procedure	Proportion of subjects with complete occlusion of the target aneurysm, ≤50% stenosis of the parent artery at the target cerebral aneurysms at 1 year as assessed by angiography, and in whom an unplanned alternative treatment of the target cerebral aneurysms had not been performed within 1 year.	1 year post procedure
Major stroke in the territory supplied by the treated artery or neurological death at 1 year post procedure	National Institute of Health Stroke Scale (NIHSS) was used to assess patients after stroke in an 11-item scale with potential scores ranging from 0 to 42. Higher values represent a worse outcome. A major stroke is defined as a new neurological event which is ipsilateral and in the vascular distribution territory of the stenting procedure and that results in an increase of ≥ 4 on the NIHSS as compared to baseline.	1 year post procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immediate procedural success rate	Intraoperative cerebrovascular imaging is performed to determine whether the investigational device positions exactly and covers the aneurysm neck effectively.	Intra-procedure
Complete aneurysm occlusion rate at 180 days and 1 year post procedure	Complete occlusion was defined as complete obliteration of the aneurysm sac, including the neck (Raymond I).	180 days, 1 year post procedure
All-cause mortality at 30 days, 180 days and 1 year post procedure	Deaths due to any cause are calculated.	30 days, 180 days and 1 year post procedure
Any stroke at 30 days, 180 days and 1 year post procedure	Incidence of any stroke including ischemic and hemorrhagic stroke.	30 days, 180 days and 1 year post procedure
Target aneurysmal hemorrhage at 180 days and 1 year post procedure	Percentage (%) of participants who experienced a Target aneurysmal hemorrhage.	180 days and 1 year post procedure
Ischemic cerebrovascular events caused by thromboembolism at 180 days and 1 year post procedure	Percentage (%) of participants who experienced ischemic cerebrovascular events caused by thromboembolism.	180 days and 1 year post procedure
Incidence of operation or device-related adverse events/serious adverse events during hospitalization, 30 days, 180 days and 1 year post procedure	Percentage (%) of participants who experienced adverse events/serious adverse events.	hospitalization, 30 days, 180 days and 1 year post procedure
Rate of Device defect	Device defects refer to the unreasonable risks that may endanger human health and life safety during the normal use of medical devices in the course of clinical trials, such as label errors, quality problems, failures, etc.	within 1 year of whole trial
Success aneurysm occlusion at 180 days and 1 year post procedure	The Raymond-Roy occlusion classification (RROC) is an angiographic classification scheme for grading the occlusion of flow diverter treated cerebral aneurysms (class I: complete obliteration, class II: residual neck, class III: residual aneurysm). Higher class represent a worse outcome. The percentage of Success aneurysm occlusion in which class 1 or 2 is achieved on the Raymond Scale at the 180 days and 1 year follow-up angiographic assessments will be evaluated.	180 days and 1 year post procedure
Complete aneurysm occlusion without significant parent artery stenosis (≤50%) or retreatment at 180 days post procedure	Proportion of subjects with complete occlusion of the target aneurysm, ≤50% stenosis of the parent artery at the target cerebral aneurysms at 180 days as assessed by angiography, and in whom an unplanned alternative treatment of the target cerebral aneurysms had not been performed within 180 days.	180 days post procedure
Major stroke in the territory supplied by the treated artery or neurological death at 180 days post procedure	National Institute of Health Stroke Scale (NIHSS) was used to assess patients after stroke in an 11-item scale with potential scores ranging from 0 to 42. Higher values represent a worse outcome. A major stroke is defined as a new neurological event which is ipsilateral and in the vascular distribution territory of the stenting procedure and that results in an increase of ≥ 4 on the NIHSS as compared to baseline.	180 days post procedure

Collaborators and Investigators

• Sponsor: Sinomed Neurovita Technology Inc.
• Collaborators: Xuanwu Hospital, Beijing
• Investigators: Principal Investigator: Hongqi Zhang, Ph.D, Xuanwu Hospital, Beijing

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2023
• Primary Completion (Actual): June 23, 2024
• Study Completion (Actual): August 30, 2024

Study Registration Dates

• First Submitted: March 6, 2023
• First Submitted That Met QC Criteria: March 16, 2023
• First Posted (Actual): March 20, 2023

Study Record Updates

• Last Update Posted (Actual): January 26, 2026
• Last Update Submitted That Met QC Criteria: January 22, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: flow diverter; endovascular therapy
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: SNSC-CFD-202204

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No