An interventional study of the Flow Diverter in Intracranial Aneurysm, sponsored by Jiangsu CED Medtech Co., Ltd. Status unknown. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-09-29.
Sponsored by Jiangsu CED Medtech Co., Ltd · Not applicable, Interventional, and Treatment
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
427 studies on the registry are indexed under Intracranial Aneurysm; 115 are open to participants now.
This study's planned enrollment of 166 is above the median of 110 across 207 interventional studies indexed under Intracranial Aneurysm.
Browse Intracranial Aneurysm studies →Jiangsu CED Medtech Co., Ltd is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
●≥18 years old and ≤75 years old, male or unpregnant female
Exclusion Criteria:
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.
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
Time frame: Twelve months after surgery
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.
Time frame: 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
Time frame: 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.
Time frame: Twelve months after surgery
No study locations are listed for this record.
This study is status unknown, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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Jiangsu CED Medtech Co., Ltd