Status:
UNKNOWN
Study on the Effectiveness and Safety of Coil System for Intracranial Aneurysm Embolization
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Conditions:
Intracranial Aneurysm
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
"Study on the effectiveness and safety of the coil system for the treatment of intracranial aneurysms embolization" was sponsored by Zhuhai Tongqiao Medical Technology Co., Ltd. The trial design is: p...
Detailed Description
"Study on the effectiveness and safety of the coil system for the treatment of intracranial aneurysms embolization" was sponsored by Zhuhai Tongqiao Medical Technology Co., Ltd. The team leader is Sha...
Eligibility Criteria
Inclusion
- An intracranial aneurysm was diagnosed by DSA examination of whole cerebral blood vessels, and it is planned to use a coil for the embolization of the target aneurysm
- The subject can understand the purpose of the research, show sufficient compliance with the research protocol, and sign an informed consent form
Exclusion
- Multiple aneurysms
- 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
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2020
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04497181
Start Date
March 1 2010
End Date
December 31 2020
Last Update
August 4 2020
Active Locations (1)
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1
Jianmin Zhang
Hangzhou, Zhejiang, China, 310000