The Flow Diverter for Treating Patients With Intracranial Aneurysms

NCT ID: NCT05060185

Last Updated: 2021-09-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 166 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-17
• Study Completion Date: 2024-05-31

Brief Summary

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

Conditions

Intracranial Aneurysm

Study Design

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

Study Groups

single arm

the patients will be treated by the trial device

Group Type: OTHER

the Flow Diverter

Intervention Type: DEVICE

Those who meet the inclusion criteria but do not meet the exclusion criteria will be enrolled through the electronic central registration system. The investigator log in to the central registration system, fill in the subject information and submit it who enroll in the study. The investigator complete the surgery and conduct relevant evaluation according to the protocol.

Interventions

the Flow Diverter

Those who meet the inclusion criteria but do not meet the exclusion criteria will be enrolled through the electronic central registration system. The investigator log in to the central registration system, fill in the subject information and submit it who enroll in the study. The investigator complete the surgery and conduct relevant evaluation according to the protocol.

Intervention Type: DEVICE

Eligibility Criteria

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

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

Sponsors

Jiangsu CED Medtech Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

CER-A-FD-01

Identifier Type: -

Identifier Source: org_study_id