Clinical trial NCT05060185: The Flow Diverter for Treating Patients With Intracranial Aneurysms
Official title: A Prospective, Multicenter,Single Arm Clinical Investigation Evaluating Safety and Effectiveness of the Flow Diverter for Treating Patients With Intracranial Aneurysms
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intracranial Aneurysm
Lead sponsor: Jiangsu CED Medtech Co., Ltd
Sponsor class: INDUSTRY
First posted: 2021-09-29
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: The rate of complete aneurysm occlusion (Raymond score: Ⅰ) confirmed by 12 postoperative menstrual imaging
timeFrame: Twelve months after surgery
Secondary outcomes:
measure: Immediate postoperative success rate
timeFrame: Immediately after
measure: The parent artery was unblocked 12 months after surgery (stenosis rate ≤50%) and no further intervention was performed
timeFrame: Twelve months after surgery
measure: The rate of self-care (mRS 0-2 points) at 12 months after operation
timeFrame: Twelve months after surgery
Other outcomes:
Locations:
Study officials:
References: