Back to resultsStudy on the Effectiveness and Safety of Coil System for Intracranial Aneurysm Embolization
Primary Purpose
Intracranial Aneurysm
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Coil embolization surgery
Sponsored by
About this trial
This is an interventional treatment trial for Intracranial Aneurysm focused on measuring intracranial aneurysms embolization
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- Jianmin ZhangRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Experimental group
Control group
Arm Description
Outcomes
Primary Outcome Measures
Embolization success rate
Embolization success rate at 6-month after surgery
Secondary Outcome Measures
Aneurysm recurrence rate
Aneurysm recurrence rate at 6-month after surgery
Full Information
NCT ID
NCT04497181
First Posted
July 26, 2020
Last Updated
July 29, 2020
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
1. Study Identification
Unique Protocol Identification Number
NCT04497181
Brief Title
Study on the Effectiveness and Safety of Coil System for Intracranial Aneurysm Embolization
Official Title
Study on the Effectiveness and Safety of Coil System for Intracranial Aneurysm Embolization
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2010 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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: prospective, multi-center, randomized, open, parallel positive control, and non-inferiority test. Purpose: To compare the data obtained by using the coil system produced by Zhuhai Tongqiao Medical Technology Co., Ltd. and the Axium Detachable Coil produced by Medtronic for the embolization of intracranial aneurysms to evaluate the effectiveness and safety of coil system for intracranial aneurysms embolization.
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 Shanghai Changhai Hospital and the Second Affiliated Hospital of Zhejiang University School of Medicine. The trial design is: prospective, multi-center, randomized, open, parallel positive control, and non-inferiority test. Purpose: To compare the data obtained by using the coil system produced by Zhuhai Tongqiao Medical Technology Co., Ltd. and the Axium Detachable Coil produced by Medtronic for the embolization of intracranial aneurysms to evaluate the effectiveness and safety of coil system for intracranial aneurysms embolization. Sample: 228 cases. The subjects will be randomly assigned to the test group or the control group, with 114 cases in each group.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Aneurysm
Keywords
intracranial aneurysms embolization
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Title
Control group
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
Coil embolization surgery
Intervention Description
Embolization of aneurysms with various coils system
Primary Outcome Measure Information:
Title
Embolization success rate
Description
Embolization success rate at 6-month after surgery
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Aneurysm recurrence rate
Description
Aneurysm recurrence rate at 6-month after surgery
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
jianmin zhang, M.D.
Phone
+86 0571 87784755
Email
zjm135@zju.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
jianmin zhang, M.D.
Organizational Affiliation
Department of neurosurgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jianmin Zhang
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianmin Zhang, M.D., Ph.D.
Phone
+86 0571 87784755.
Email
zjm135@zju.edu.cn
First Name & Middle Initial & Last Name & Degree
Jianmin Zhang, M.D.，Ph.D.
12. IPD Sharing Statement
Learn more about this trial
Study on the Effectiveness and Safety of Coil System for Intracranial Aneurysm Embolization
We'll reach out to this number within 24 hrs