Safety and Effectiveness of ENTERPRISE 2 Device in the Endovascular Treatment of Intracranial Ane… (NCT04289480) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Safety and Effectiveness of ENTERPRISE 2 Device in the Endovascular Treatment of Intracranial Aneurysms
China164 participantsStarted 2020-07-30
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. Severe co-morbidity associated with a life-expectancy of less than twelve months as determined by the investigator;
✕. 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;