Medina Embolization Device In Neurovascular Aneurysm Study
Terminated
- Conditions
- Intracranial Aneurysm
- Registration Number
- NCT02982200
- Lead Sponsor
- Medtronic Neurovascular Clinical Affairs
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 15
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Complete aneurysm occlusion as defined by the Modified Raymond-Roy Classification (MRRC) 12 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
Azienda Ospedaliera Ospedale Niguarda Cà Granda
🇮🇹Milan, Italy
Universitätsklinikum Christian Doppler Klinik Salzburg
🇦🇹Salzburg, Austria
Hospital Fundación Jiménez Díaz
🇪🇸Madrid, Spain