The purpose of this Post-Market Clinical Follow-up study is to assess the safety and performance of the Trenza in the treatment of intracranial aneurysms.
Prospective, multi-center, single-arm, post-market follow-up study conducted in Europe for the treatment of patients with saccular intracranial aneurysms.
Study Type
OBSERVATIONAL
Enrollment
150
Salzburg University Hopsital
Salzburg, Austria
Helsinski University Hospital
Helsinki, Finland
Turun yliopistollinen keskussairaala
Safety primary outcome measure
The primary safety endpoint of this study is stroke-related neurologic death, or major ipsilateral or disabling stroke in the territory supplied by the treated artery, occurring within 12 months post-procedure as adjudicated by an independent Clinical Events Committee (CEC) * With major ipsilateral stroke defined as a stroke associated with an increase in NIHSS score ≥ 4 points persisting ≥ 24 hours, and; * With disabling stroke defined as a stroke that results in a modified Rankin Scale (mRS) score ≥ 3 assessed at a minimum of 90 days post-stroke event.
Time frame: 1 year (± 6 months)
Effectiveness primary outcome measure
The primary effectiveness endpoint of this study is adequate aneurysm occlusion without retreatment or significant parent artery stenosis (\>50% stenosis). The determination of adequate aneurysm occlusion using Raymond-Roy classification will be made if either of the following criteria are met: * 100% occlusion (Raymond Class I) demonstrated by angiographic measurement at 12 months (+6/-3 months) post-procedure, or * Stable Raymond Class II demonstrated on 2 serial angiographic measurements obtained a minimum of 6 months (± 1 month) apart
Time frame: 1 year (± 6 months)
Safety secondary outcome measure
The secondary safety endpoint of this study is any stroke event occurring through 12 months post-procedure where a stroke event is defined as: • Rapidly developing clinical signs of focal (or global) disturbance of cerebral function lasting more than 24 hours with no apparent cause other than of vascular origin, including ischemic stroke and/or hemorrhagic stroke (i.e., intraparenchymal hemorrhage \[IPH\], subarachnoid hemorrhage \[SAH\], subdural hemorrhage \[SDH\], epidural hemorrhage \[EDH\]) accompanied with radiological evidence.
Time frame: 1 year (± 6 months)
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Turku, Finland
Bordeaux Hopsital
Bordeaux, France
Brest Hospital
Brest, France
HCL Lyon
Lyon, France
Montpellier Hospital
Montpellier, France
APHP Bicêtre
Paris, France
Purpan Hospital
Toulouse, France
Universitätsklinikum Knappschaftskrankenhaus Bochum GmbH
Bochum, Germany
...and 8 more locations