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

NCT05774782 | Completed DMC

• 1 other identifier: SNSC-CFD-202204
• Study Type: interventional
• Target: 143
• Locations: 1 country
• Sites: 1

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

Conditions

Cerebral Aneurysm; Cerebral Aneurysm Unruptured

Keywords

flow diverter; endovascular therapy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (11)

• Immediate procedural success rate

  Intra-procedure

• Complete aneurysm occlusion rate at 180 days and 1 year post procedure

  180 days, 1 year post procedure

• Success aneurysm occlusion at 180 days and 1 year post procedure

  180 days and 1 year post procedure

• Complete aneurysm occlusion without significant parent artery stenosis (≤50%) or retreatment at 180 days post procedure

  180 days post procedure

• All-cause mortality at 30 days, 180 days and 1 year post procedure

  30 days, 180 days and 1 year post procedure

Study Arms (1)

Cerebral flow diverter

EXPERIMENTAL

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

Device: Cerebral flow diverter

Interventions

Cerebral flow diverter 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.

Cerebral flow diverter

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.
• Severe arteriosclerosis or tortuosity of intracranial artery, and the device is difficult to reach the target vessel.
• Subject with target aneurysm previously treated with craniotomy or other endovascular interventional therapy.
• 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).
• Severe respiratory system, liver and kidney diseases (such as creatinine ≥ 3.0 mg/dL (except dialysis)) or blood coagulation disorders before operation.
• Platelet count is less than 100×109/L, international normalized ratio (INR) is more than 1.5.
• Hospitalized surgical treatment within the previous 30 days or planned within the next 180 days after operation.
• Severe neurological deficit that renders the patient incapable of living independently (modified Rankin score ≥3).
• The survival expectation is less than 1 year.
• All subjects who are participating in other drug/medical device clinical trials and have not completed the programme requirements
• Inapplicable for this study at the investigators' viewpoints.

Sponsors & Collaborators

• Sinomed Neurovita Technology Inc.: lead
• Xuanwu Hospital, Beijing: collaborator

Study Sites (1)

Xuanwu Hospital Capital Medical University

Beijing, China

Location

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

• Hongqi Zhang, Ph.D

  Xuanwu Hospital, Beijing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2023
• First Posted: March 20, 2023
• Study Start: March 27, 2023
• Primary Completion: June 23, 2024
• Study Completion: August 30, 2024
• Last Updated: January 26, 2026

Record last verified: 2026-01

Locations

CN (1)