Post market surveillance registry
An observational, prospective, multi-center, single-arm registry to provide continuing evaluation and periodic reporting of safety and effectiveness of Medtronic Neurovascular market-released products used in the treatment of Intracranial aneurysms and Acute Ischemic Stroke. MDT16056 and MDT17077 are conducted under the Product Surveillance Registry (NCT01524276).
Study Type
OBSERVATIONAL
Enrollment
4,000
Embolization of aneurysms
Revascularization of an intracranial blood vessel
The clinical success rate defined as complete occlusion of target aneurysm without retreatment or significant artery stenosis (≤ 50%).
For Intracranial Aneurysm the primary outcome is the clinical success rate defined as complete occlusion of target aneurysm without retreatment or significant artery stenosis (≤ 50%).
Time frame: 1 year
Functional Independence: mRS score ≤ 2
For Acute ischemic stroke the primary outcome is functional Independence: modified Rankin Scale (mRS) score ≤ 2
Time frame: 90 days
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ENERI
Buenos Aires, Argentina
COMPLETEDGold Coast University Hospital
Southport, Australia
ACTIVE_NOT_RECRUITINGUniversitätsklinikum Christian Doppler Klinik Salzburg
Salzburg, Austria
RECRUITINGZiekenhuis Oost Limburg - Campus Sint-Jan
Genk, Belgium
COMPLETEDUniversitair Ziekenhuis Gent
Ghent, Belgium
COMPLETEDXuanwu Hospital Capital Medical University
Beijing, China
COMPLETEDChongqing University Three Gorges Hospital
Chongqing, China
COMPLETEDFirst Affiliated Hospital of Jiamusi University
Jiamusi, China
TERMINATEDThe Affiliated Hospital of Jinggangshan University
Ji’an, China
COMPLETEDKaifeng Central Hospital
Kaifeng, China
TERMINATED...and 89 more locations