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 range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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;