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

NCT ID: NCT05774782

Last Updated: 2026-01-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 143 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-27
• Study Completion Date: 2024-08-30

Brief Summary

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

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.

Conditions

Cerebral Aneurysm; Cerebral Aneurysm Unruptured

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cerebral flow diverter

The cerebral flow diverter in the endovascular treatment of wide-necked cerebral aneurysms

Group Type: EXPERIMENTAL

Cerebral flow diverter

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xuanwu Hospital, Beijing

OTHER

Sponsor Role: collaborator

Sinomed Neurovita Technology Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hongqi Zhang, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Xuanwu Hospital, Beijing

Locations

Xuanwu Hospital Capital Medical University

Beijing, , China

Countries

China

Other Identifiers

SNSC-CFD-202204

Identifier Type: -

Identifier Source: org_study_id