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)
Incidence of aneurysm recanalization — at 180 days post procedure Incidence of aneurysm recanalization (at 180 days) = number of target aneurysm recanalization (at 180 days) ÷ total number of target aneurysms receiving follow-up × 100%. The results of aneurysm angiography at 180-day follow-up will be obtained through DSA, and the post-procedure immediate aneurysm recanalization shown in angiograms will be graded as per the Raymond-Roy Classification Scale.
The Raymond-Roy Classification at each follow-up time point increased by ≥ one class relative to that immediately after the procedure is defined as recanalization (e.g., Class I immediately after the procedure, Class II at 180-day follow-up).
Trial sites (10)
Facility
City
Region
Status
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
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.
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