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

Zhejiang University

Status

Unknown

Conditions

Intracranial Aneurysm

Treatments

Device: Coil embolization surgery

Study type

Interventional

Funder types

Other

Identifiers

NCT04497181

I2017001223

Details and patient eligibility

About

"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.

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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