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

NCT04289480 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 164

Last updated 2026-05-08

No results posted yet for this study

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.

Conditions

  • Intracranial Aneurysm

Interventions

DEVICE

ENTERPRISE 2 device

The ENTERPRISE 2 Vascular Reconstruction Device is intended for use with occlusive devices in the treatment of intracranial aneurysms.

Sponsors & Collaborators

  • Johnson & Johnson Medical (Shanghai) Ltd.

    collaborator INDUSTRY

  • Medos International SARL

    lead INDUSTRY

Principal Investigators

  • Xinjian Yang, Professor · Beijing Tiantan Hospital

  • Shiqing Mu, Professor · Beijing Tiantan Hospital

  • Qingrong Zhang, Professor · The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

  • Yuxiang Gu, Professor · Huashan Hospital Shanghai Medical college, Fudan University

  • Chuanzhi Duan, Professor · Southern Medical University, China

  • Shu Wan, Professor · Zhejiang Hospital

  • Bo Yu, Professor · Shengjing Hospital

  • Yang Wang, Professor · The First Affiliated Hospital of Nanchang University

  • Sheng Guan, Professor · The First Affiliated Hospital of Zhengzhou University

  • Wohua Zhao, Professor · Union Hospital, Tongji Medical College, Huazhong University of Science & Technology

  • Xinjian Yang, Professor · Beijing Anzhen Hospital

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-30
Primary Completion
2022-04-22
Completion
2026-09-10
FDA Device
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04289480 on ClinicalTrials.gov