Status:
ACTIVE_NOT_RECRUITING
Safety and Effectiveness of ENTERPRISE 2 Device in the Endovascular Treatment of Intracranial Aneurysms
Lead Sponsor:
Medos International SARL
Collaborating Sponsors:
Johnson & Johnson Medical (Shanghai) Ltd.
Conditions:
Intracranial Aneurysm
Eligibility:
All Genders
18-80 years
Brief 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 c...
Detailed Description
This is a prospective, multicenter, single-arm observational study, in which enrolled patients will be implanted with the ENTERPRISE 2 for evaluation of safety and effectiveness of ENTERPRISE 2 in rea...
Eligibility Criteria
Inclusion
- 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;
- Aged between 18 years and 80 years of age the time of consent;
- Patient has been diagnosed with ruptured (Hunt-Hess Grade I-III) or unruptured intracranial aneurysm and requires the endovascular treatment;
- Parent vessel with a diameter of ≥2.5 mm and ≤4 mm;
- Patient is willing to return to the investigational site for the post-procedure follow-up evaluations.
Exclusion
- Severe co-morbidity associated with a life-expectancy of less than twelve months as determined by the investigator;
- Poor clinical condition with modified Rankin Scale (mRS) score ≥4;
- Having prior or potential severe allergic reaction to contrast medium;
- Known allergies to any of the device components, including Enterprise 2 and PROWLER® SELECT™ Plus Infusion Catheter;
- 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);
- Arteriovenous malformation (AVM) in the territory of the target aneurysm;
- Unsuitable for the antithrombotic and/or anticoagulant therapies;
- Implantation of an intracranial stent associated with aneurysm or symptom distribution within 12 weeks prior to signature of Informed Consent Form;
- Implantation of a carotid stent associated with aneurysm or symptom distribution within 12 weeks prior to signature of Informed Consent Form;
- Evidence of active infection;
- Pregnant or lactating women;
- 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;
- Pre-planned staged procedure of target aneurysms.
Key Trial Info
Start Date :
July 30 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 10 2026
Estimated Enrollment :
164 Patients enrolled
Trial Details
Trial ID
NCT04289480
Start Date
July 30 2020
End Date
September 10 2026
Last Update
October 10 2025
Active Locations (10)
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1
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100029
2
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100070
3
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China
4
The first affiliated hospital of Zhengzhou university
Zhengzhou, Henan, China, 450052