The Flow Diverter for Treating Patients With Intracranial Aneurysms

A Prospective, Multicenter,Single Arm Clinical Investigation Evaluating Safety and Effectiveness of the Flow Diverter for Treating Patients With Intracranial Aneurysms

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

Study Overview

• Status: Not yet recruiting
• Conditions: Intracranial Aneurysm
• Intervention / Treatment: Device: the Flow Diverter

• Study Type: Interventional
• Enrollment (Anticipated): 166
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: single arm; the patients will be treated by the trial device

Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The rate of complete aneurysm occlusion (Raymond score: Ⅰ) confirmed by 12 postoperative menstrual imaging	The cerebral vascular imaging examination 12 months after the operation was performed to analyze whether the aneurysm was completely occluded. Aneurysm occlusion images were reviewed by clinicians and the core laboratory respectively. When the evaluation results were different from those determined by clinicians, the results of the core laboratory should prevail	Twelve months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immediate postoperative success rate	The intraoperative blood flow guidance device was successfully released, and the implant was accurately located by angiography after placement, and the proportion of subjects who could effectively cover aneurysma neck was calculated.	Immediately after
The parent artery was unblocked 12 months after surgery (stenosis rate ≤50%) and no further intervention was performed	The clinician and the core laboratory will evaluate the results respectively. If the evaluation results are different from those determined by the clinician, the core laboratory results shall prevail	Twelve months after surgery
The rate of self-care (mRS 0-2 points) at 12 months after operation	MRS is a disability assessment to assess the independent living standard of postoperative patients and analyze the outcome of aneurysm surgery.	Twelve months after surgery

Collaborators and Investigators

• Sponsor: Jiangsu CED Medtech Co., Ltd

Study record dates

Study Major Dates

• Study Start (Anticipated): October 17, 2021
• Primary Completion (Anticipated): February 28, 2024
• Study Completion (Anticipated): May 31, 2024

Study Registration Dates

• First Submitted: September 14, 2021
• First Submitted That Met QC Criteria: September 27, 2021
• First Posted (Actual): September 29, 2021

Study Record Updates

• Last Update Posted (Actual): September 29, 2021
• Last Update Submitted That Met QC Criteria: September 27, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: CER-A-FD-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No