Clinical trial NCT04497181: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Intracranial Aneurysm
Keywords: intracranial aneurysms embolization
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2020-08-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Embolization success rate
timeFrame: 6 months
Secondary outcomes:
measure: Aneurysm recurrence rate
timeFrame: 6 months
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Jianmin Zhang
state: Zhejiang
Study officials:
affiliation: Department of neurosurgery
name: jianmin zhang, M.D.
role: PRINCIPAL_INVESTIGATOR
References: