Intracranial Aneurysm
Conditions
Keywords
Embolization Device, Medina, Rupture Intracranial Aneurysm, Unrupture Intracranial Aneurysm
Brief summary
A global prospective, multi-center, single-arm, post-market clinical follow-up (PMCF) study conducted to assess the performance of the Medina Embolization Device when used in unruptured and ruptured intracranial aneurysms.
Interventions
None listed
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Medtronic Neurovascular Clinical Affairs
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Subject has provided written informed consent using the Ethics Committee-approved consent form and agrees to comply with protocol requirements * Subject is 18- 85 years old * Subject has a ruptured or unruptured saccular intra-cranial aneurysm amenable to be treated with the Medina Embolization Device
Exclusion criteria
* Aneurysm is partially thrombosed * Aneurysm has been previously treated with surgery or endovascular therapy * Subject has had major brain surgery including endovascular procedures within the past 30 days * Vessel characteristics (tortuosity, stenosis, morphology) preclude safe endovascular access to the aneurysm * Subject is pregnant or breast-feeding or wishes to become pregnant during the length of the study participation * The Investigator determines that the validity of the study outcomes may be compromised by the subject's enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete aneurysm occlusion as defined by the Modified Raymond-Roy Classification (MRRC) | 12 months |
Countries
Austria, Italy, Spain
Outcome results
None listed