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

Active Not RecruitingN/A

Sponsor: Medos International SARL

Conditions: Intracranial Aneurysm

Interventions: ENTERPRISE 2 device

Countries: China

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 overview

Sex: ALL

Age: 18 Years to 80 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

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.

Locations (10)

Beijing, Beijing Municipality, China
Beijing, Beijing Municipality, China
Guangzhou, Guangdong, China
Zhengzhou, Henan, China
Wuhan, Hubei, China
Nanjing, Jiangsu, China
Nanchang, Jiangxi, China
Shenyang, Liaoning, China
Shanghai, Shanghai Municipality, China
Hangzhou, Zhejiang, China