The Flow Diverter for Treating Patients With Intracranial Aneurysms

Jiangsu CED Medtech

Status: Not yet enrolling

Conditions: Intracranial Aneurysm

Treatments: Device: the Flow Diverter

Study type: Interventional

Funder types: Industry

Identifiers

NCT05060185

CER-A-FD-01

Details and patient eligibility

About

To evaluate the efficacy and safety of the blood flow guide device manufactured by Jiangsu Changyida Medical Technology Co., Ltd. for endovascular embolization of intracranial aneurysms

Enrollment: 166 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

●≥18 years old and ≤75 years old, male or unpregnant female

• Untreated and unruptured intracranial wide-necked aneurysm confirmed by preoperative imaging diagnosis (wide-necked aneurysm was defined as the tumor neck ≥4mm or the tumor body/tumor neck ratio <2)
• The target aneurysm is planned to be treated with blood flow guidance device only, without the need to complete the treatment by stages
• The width of tumor neck should be less than 30mm
• Imaging measurements of the tumor parent artery showed that the diameter was 1.5mm ~ 6.5mm
• The subject or legal guardian can understand the purpose of the study, demonstrate sufficient compliance with the study protocol, and sign the informed consent

Exclusion criteria

• The target aneurysm has previously received craniotomy clipping or other endovascular interventional treatment
• Target aneurysms were haemacular aneurysms, pseudoaneurysms, arteriovenous malformations and moyamoya disease related aneurysms
• DSA suggested vascular path tortuosity or severe arteriosclerosis, and it was difficult for the instrument to reach the target vessel
• Contraindications to dual antiplatelet therapy and anticoagulation therapy
• Patients with known clear allergy to nickel-titanium alloys and platinum-tungsten alloys
• People with known severe allergy to contrast media (excluding rash)
• patients with known dementia or mental illness
• Preoperative complicated with serious heart, liver, kidney, respiratory system diseases and bleeding disorders
• Life expectancy is less than one year
• Is participating in, or may participate in, any other drug or medical device clinical trial after inclusion in this clinical trial
• Other conditions determined by the investigator to be unsuitable for participation in this clinical trial

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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166 participants in 1 patient group

single arm

Other group

Description:

the patients will be treated by the trial device

Treatment:

Device: the Flow Diverter