Clinical Safety and Efficacy of Flow-diverter in the Treatment of Intracranial Aneurysms
ConditionFlow Diverter
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorHuashan Hospital
About this trial
To collect the safety and effectiveness data of flow-di in the treatment of intracranial aneurysms in real-world clinical practice, verify its classification of treatment strategies for aneurysms of different locations and shapes, and optimize postoperative medication regimen, provide long-term evidence-based basis for clinical treatment of intracranial aneurysms, and build a database.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
intracranial aneurysm diagnosed by CTA, MRA or DSA (Including wide-necked aneurysms (neck width ≥4mm or Dome/neck ratio \<2), saccular, fusiform aneurysms, recurrent saccular aneurysms and dissecting aneurysms, and the diameter of the parent vessel ≥ 2.0 mm and ≤ 6.0 mm
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Aneurysm complete occlusion rate 12 months after surgery
Time frame
12 months after surgerySecondary outcomes
1
Aneurysm complete occlusion rate 6 months after surgery
Time frame
6 months after surgery2
Immediate success rate
Time frame
Immediate3
In-stent stenosis (>50% stenosis) rate 6,12 months after surgery
Time frame
6,12 months after surgery4
Incidence of ipsilateral disabled stroke 3 months after surgery, 6 months after surgery, and 12 months after surgery
Time frame
3 months after surgery, 6 months after surgery, and 12 months after surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Huashan Hospital
Lead sponsor
Xinqiao Hospital of Chongqing
Collaborator
Ningbo No.2 Hospital
Collaborator
Eighth Affiliated Hospital, Sun Yat-sen University
Collaborator
Second Affiliated Hospital of Nanchang University
Collaborator
Jiangxi Provincial People's Hopital
Collaborator
Zhengzhou Central Hospital
Collaborator
Xuchang Central Hospital
Collaborator
Second People's Hospital of Hunan
Collaborator
People's Hospital Of Ningxiang City
Collaborator
The First People's Hospital of Changde City
Collaborator
HUANG GANG Central Hospital
Collaborator
Xianning Central Hospital
Collaborator
Jingzhou Central Hospital
Collaborator
Yichang Central People's Hospital
Collaborator
The First People's Hospital of Changzhou
Collaborator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Collaborator
Northern Jiangsu People's Hospital
Collaborator
Suzhou Municipal Hospital
Collaborator
Jiangsu Taizhou People's Hospital
Collaborator
Huadong Hospital
Collaborator
RenJi Hospital
Collaborator
Shanghai Zhongshan Hospital
Collaborator
Shanghai Fourth People's Hospital
Collaborator
Shanghai Donglei Brain Hospital
Collaborator
Shanghai Pudong New Area People's Hospital
Collaborator
Shanghai East Hospital of Tongji University
Collaborator
First Affiliated Hospital Xi'an Jiaotong University
Collaborator
Second Affiliated Hospital of Xi'an Jiaotong University
Collaborator
Tangshan Gongren Hospital
Collaborator
The Second Hospital of Hebei Medical University
Collaborator
Hebei General Hospital
Collaborator
Xingtai People's Hospital
Collaborator
Peking University First Hospital
Collaborator
THE AFFILIATED SUZHOU HOSPITAL OF NANJING UNIVERSITY MEDICAL SCHOOL
Collaborator
The Second Affiliated Hospital of Kunming Medical University
Collaborator
Source ClinicalTrials.gov