🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT04289480
Active, not recruiting Observational

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

NCT04289480 · tracked via the Priya Life Science China tracker
Sponsor
Medos International SARL
Phase
Observational
Started
2020-07-30
Last updated
2026-08-28

Condition(s) studied

Intracranial Aneurysm

Investigational drug(s) / intervention(s)

ENTERPRISE 2 device

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

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: 1. Patient (or his/her legal representative) understands the nature of the procedure and provides voluntary written informed consent for the use of his/her peri-procedural and follow-up data; 2. Aged between 18 years and 80 years of age the time of consent; 3. Patient has been diagnosed with ruptured (Hunt-Hess Grade I-III) or unruptured intracranial aneurysm and requires the endovascular treatment; 4. Parent vessel with a diameter of ≥2.5 mm and ≤4 mm; 5. Patient is willing to return to the investigational site for the post-procedure follow-up evaluations. Exclusion Criteria: 1. Severe co-morbidity associated with a life-expectancy of less than twelve months as determined by the investigator; 2. Poor clinical condition with modified Rankin Scale (mRS) score ≥4; 3. Having prior or potential severe allergic reaction to contrast medium; 4. Known allergies to any of the device components, including Enterprise 2 and PROWLER® SELECT™ Plus Infusion Catheter; 5. Angiogram demonstrating that the aneurysm is not appropriate for endovascular treatment (i.e. severe intracranial vessel tortuosity, stenosis, intracranial vasospasm not responsive to medical therapy); 6. Arteriovenous malformation (AVM) in the territory of the target aneurysm; 7. Unsuitable for the antithrombotic and/or anticoagulant therapies; 8. Implantation of an intracranial stent associated with aneurysm or symptom distribution within 12 weeks prior to signature of Informed Consent Form; 9. Implantation of a carotid stent associated with aneurysm or symptom distribution within 12 weeks prior to signature of Informed Consent Form; 10. Evidence of active infection; 11. Pregnant or lactating women; 12. Having participated in clinical studies of other investigational drugs or devices within 30 days prior to signature of Informed Consent Form, excluding epidemiological studies of observational nature or natural history or not involving intervention; 13. Pre-planned staged procedure of target aneurysms.

Primary outcome measure(s)

Trial sites (10)

FacilityCityRegionStatus
Beijing Anzhen Hospital, Capital Medical University Beijing Beijing Municipality
Beijing Tiantan Hospital, Capital Medical University Beijing Beijing Municipality
Zhujiang Hospital of Southern Medical University Guangzhou Guangdong
The first affiliated hospital of Zhengzhou university Zhengzhou Henan
Union Hospital, Tongji Medical College, Huazhong University of Science & Technology Wuhan Hubei
Nanjing Drum Tower Hospital Nanjing Jiangsu
The first affiliated hospital of Nanchang university Nanchang Jiangxi
Shengjing Hospital of China Medical University Shenyang Liaoning
Huashan Hospital Shanghai Medical college, Fudan University Shanghai Shanghai Municipality
Zhejiang Hospital Hangzhou Zhejiang

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04289480 on ClinicalTrials.gov ↗ ← All trials in China