The Flow Diverter for Treating Patients With Intracranial Aneurysms

NCT05060185 | Unknown

• 1 other identifier: CER-A-FD-01
• Study Type: interventional
• Target: 166
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Immediate postoperative success rate

  Immediately after

• The parent artery was unblocked 12 months after surgery (stenosis rate ≤50%) and no further intervention was performed

  Twelve months after surgery

• The rate of self-care (mRS 0-2 points) at 12 months after operation

  Twelve months after surgery

Study Arms (1)

single arm

OTHER

the patients will be treated by the trial device

Device: the Flow Diverter

Interventions

the Flow Diverter 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.

single arm

Eligibility Criteria

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

You may qualify if:

• ●≥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

You may not qualify if:

• 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
• Other conditions determined by the investigator to be unsuitable for participation in this clinical trial

Sponsors & Collaborators

• Jiangsu CED Medtech Co., Ltd: lead

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 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: September 14, 2021
• First Posted: September 29, 2021
• Study Start: October 17, 2021
• Primary Completion: February 28, 2024
• Study Completion: May 31, 2024
• Last Updated: September 29, 2021

Record last verified: 2021-08