Aneurysms, Cerebrovascular Disorders, Intracranial Arterial Diseases, Vascular Diseases
Conditions
Keywords
ev3 Neurovascular, aneurysms, cerebrovascular, endovascular, neurovascular therapies, RACER, AXIUM, The AXIUM Progressive Coil System, ev3, MTI, Micro Therapeutics, FX detachable coil system, K060747, brain diseases
Brief summary
The data collected in this study will be used to support International Regulatory submissions. The study objective is to evaluate the continued safety and efficacy of the AXIUM Progressive Coil System. This Device has been used clinically at approximately 150 Institutions under FDA 510(k) clearance since April 24, 2007. The device received CE authorization on June 30, 2007. Through December 2007, more than 1000 patients have been treated with the AXIUM Coils.
Interventions
DEVICEThe AXIUM Progressive Coil System
Embolization of aneurysm
Sponsors
Medtronic Neurovascular Clinical Affairs
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient or patient's legally authorized representative has signed and dated an Informed Consent Form * Must be at least 18 years of age * Aneurysm location, angio-architecture, morphology, or medical condition, is considered by the neurosurgical / interventional team to be at very high risk for management by traditional operative techniques, or aneurysm is considered to be inoperable * Patient is willing to conduct follow-up visits
Exclusion criteria
* Aneurysm was previously treated * Patient has a cerebral aneurysm with a location, angioarchitecture or morphology that presents an unacceptable risk of morbidity due to the Study procedures * Patient is participating in another clinical research Study * Patient has a medical, social or psychological condition, which precludes the patient from receiving Study required treatment, evaluation, procedures and follow-up * Female patient is pregnant or breast-feeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent Occlusion | Defined in protocol |
Secondary
| Measure | Time frame |
|---|---|
| Morbidity/Mortality | Defined in protocol |
Countries
United States
Outcome results
None listed