Study on the Effectiveness and Safety of Coil System for Intracranial Aneurysm Embolization

Intracranial Aneurysm Clinical Trial

Official title:

Study on the Effectiveness and Safety of Coil System for Intracranial Aneurysm Embolization

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04497181
• Other study ID #: I2017001223
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2010
• Est. completion date: December 31, 2020

Study information

• Verified date: July 2020
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: jianmin zhang, M.D.
• Phone: +86 0571 87784755
• Email: zjm135[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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*10? 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

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm

Intervention

Device:
• Coil embolization surgery
Embolization of aneurysms with various coils system

Locations

Country	Name	City	State
China	Jianmin Zhang	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Embolization success rate	Embolization success rate at 6-month after surgery	6 months
Secondary	Aneurysm recurrence rate	Aneurysm recurrence rate at 6-month after surgery	6 months