Study on the Effectiveness and Safety of Coil System for Intracranial Aneurysm Embolization
NCT ID: NCT04497181
Last Updated: 2020-08-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
20 participants
INTERVENTIONAL
2010-03-01
2020-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Experimental group
Coil embolization surgery
Embolization of aneurysms with various coils system
Control group
Coil embolization surgery
Embolization of aneurysms with various coils system
Interventions
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Coil embolization surgery
Embolization of aneurysms with various coils system
Eligibility Criteria
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Inclusion Criteria
* The subject can understand the purpose of the research, show sufficient compliance with the research protocol, and sign an informed consent form
Exclusion Criteria
* Blood alveolar aneurysm, fusiform aneurysm, pseudoaneurysm, dissecting aneurysm, infectious aneurysm with arteriovenous malformation
* mRS score ≥ 3
* Hunt and Hess rating≥4
* Emergency ruptured aneurysms who need stent
* The target aneurysm has previously been treated with vascular embolization or surgery
* Patients with severe stenosis of the tumor-bearing artery
* PLT\<60\*10⁹ or INR\>1.5
* Having vital organ failure or other serious diseases
* Received major surgery within 30 days before enrollment, or planned to undergo surgery within 90 days after enrollment
* History of allergy or contraindications to antiplatelet drugs, anticoagulant drugs, anesthetics, or contrast agents
* Patiens with a history of allergies to platinum and tungsten metals
* Life expectancy \<12 months
* Pregnant or breastfeeding women
* Participated in other drug or device clinical trials within 1 month before signing the informed consent
* Other situations that the researcher judges are not suitable for inclusion
18 Years
80 Years
ALL
No
Sponsors
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Second Affiliated Hospital, School of Medicine, Zhejiang University
OTHER
Responsible Party
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Principal Investigators
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jianmin zhang, M.D.
Role: PRINCIPAL_INVESTIGATOR
Department of neurosurgery
Locations
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Jianmin Zhang
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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I2017001223
Identifier Type: -
Identifier Source: org_study_id
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