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Safety and Effectiveness of ENTERPRISE 2 Device in the Endovascular Treatment of Intracranial Aneurysms
Sponsor: Medos International SARL
Summary
The study is designed to evaluate the safety and effectiveness of ENTERPRISE 2 vascular reconstruction device and delivery system (hereinafter referred to as ENTERPRISE 2) to facilitate endovascular coil embolization of intracranial aneurysms.
Official title: ENTERPRISE 2 Vascular Reconstruction Device and Delivery System Registry: A Multicenter, Prospective, Single-arm Observational Study to Evaluate the Safety and Effectiveness With the Device to Facilitate Endovascular Coil Embolization of Intracranial Aneurysms
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
OBSERVATIONAL
Enrollment
164
Start Date
2020-07-30
Completion Date
2026-09-10
Last Updated
2026-03-13
Healthy Volunteers
No
Conditions
Interventions
ENTERPRISE 2 device
The ENTERPRISE 2 Vascular Reconstruction Device is intended for use with occlusive devices in the treatment of intracranial aneurysms.
Locations (10)
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China
The first affiliated hospital of Zhengzhou university
Zhengzhou, Henan, China
Union Hospital, Tongji Medical College, Huazhong University of Science & Technology
Wuhan, Hubei, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
The first affiliated hospital of Nanchang university
Nanchang, Jiangxi, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
Huashan Hospital Shanghai Medical college, Fudan University
Shanghai, Shanghai Municipality, China
Zhejiang Hospital
Hangzhou, Zhejiang, China