Safety and Effectiveness of ENTERPRISE 2 Device in the Endovascular Treatment of Intracranial Aneurysms
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A vizsgálat adatai
- Ki végzi
- Medos International SARL
- Azonosító
- NCT04289480
- A regiszteradat frissítve
- 2026. november 4.
- Eredeti leírás
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.A teljes eredeti leírásKevesebb
ENTERPRISE 2 Vascular Reconstruction Device and Delivery System Registry: A Multicenter, Prospective, Single-arm Observational Study to Evaluate the Safety and Effectiveness With the Device to Facilitate Endovascular Coil Embolization of Intracranial Aneurysms
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.
Bevonási feltételek: 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.
Kizáró feltételek: Having prior or potential severe allergic reaction to contrast medium; 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); 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; 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; Poor clinical condition with modified Rankin Scale (mRS) score ≥4; Known allergies to any of the device components, including Enterprise 2 and PROWLER® SELECT™ Plus Infusion Catheter; Evidence of active infection; Severe co-morbidity associated with a life-expectancy of less than twelve months as determined by the investigator; Arteriovenous malformation (AVM) in the territory of the target aneurysm; Pregnant or lactating women; Pre-planned staged procedure of target aneurysms.