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NCT04289480

Safety and Effectiveness of ENTERPRISE 2 Device in the Endovascular Treatment of Intracranial Aneurysms

Sponsor: Medos International SARL

View on ClinicalTrials.gov

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

Interventions

DEVICE

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