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

Sinomed Neurovita Technology

Status: Completed

Conditions: Cerebral Aneurysm; Cerebral Aneurysm Unruptured

Treatments: Device: Cerebral flow diverter

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05774782

SNSC-CFD-202204

Details and patient eligibility

About

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

Full 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.

Enrollment: 143 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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143 participants in 1 patient group

Cerebral flow diverter

Experimental group

Description:

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

Treatment:

Device: Cerebral flow diverter