The objective of this Post-Market Clinical Follow-up (PMCF) is to confirm the performance and safety of the Codman Enterprise® 2 when used in conjunction with endovascular coil embolization of ruptured or non-ruptured intracranial aneurysms.
Study Type
OBSERVATIONAL
Enrollment
26
Stenting Assisted coiling procedure
Helios Klinikum Berlin
Berlin, Germany
Universitätslklinikum der Ruhr Universität Bochum
Bochum, Germany
Universitätsklinikum Hamburg Eppendorf
Eppendorf, Germany
Asklepios Klinik Atona
Hamburg, Germany
Incidence of Major Ipsilateral Stroke and/or Death due to related neurological event in subjects with a non-ruptured aneurysm.
any a new neurological event, which is ipsilateral and in the vascular distribution territory of the stenting procedure and that results in an increase of ≥ 4 on the National Institute of Health Stroke Scale (NIHSS), as compared to baseline and persists for greater than 24 hours
Time frame: 6 months
Incidence of Successful Aneurysm treatment without retreatment
aneurysms categorized as adequate occlusion (i.e., scored as complete \[100%\] or near completely occluded \[90-99%\]), without additional procedures for treatment of the aneurysm since the index procedure.
Time frame: 6 Months
Incidence of Successful Aneurysm treatment
aneurysms categorized as adequate occlusion (i.e., scored as complete \[100%\] or near completely occluded \[90-99%\]), without additional procedures for treatment of the aneurysm since the index procedure.
Time frame: 12 months
Incidence of Aneurysm Recanalization
any increase in aneurysm filling, compared to the previous study-specified angiographic assessment, resulting in a change in (i.e., worsening of) the 3-point scale.
Time frame: 6 & 12 Months
Incidence of Retreatment
aneurysms with any additional treatment of the target aneurysm after the index procedure (regardless of whether retreatment is by surgery or endovascular treatment) due to recanalization, rupture, bleeding or staged procedure.
Time frame: 6 & 12 Months
Incidence of New Neurological Deficits
subjects who have an increase in mRS greater than 2 from baseline related to stroke or death
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Universitätsklinikum Schl.-Holst. Campus Lübeck
Lübeck, Germany
Hospital Universitario de Navarra
Pamplona, Spain
Inselspital-Universitätsspital Bern
Bern, Switzerland
Hôpitaux Universitaires de Genève
Geneva, Switzerland
Spire Leeds Hospital
Leeds, United Kingdom
Queen's Hospital of Romford
Romford, United Kingdom
Time frame: 30 Days, 6 & 12 Months
Incidence of Major Ipsilateral Stroke and/or Death due to related neurological event
any a new neurological event, which is ipsilateral and in the vascular distribution territory of the stenting procedure and that results in an increase of ≥ 4 on the National Institute of Health Stroke Scale (NIHSS), as compared to baseline and persists for greater than 24 hours
Time frame: 30 Days and 12 Months
Incidence of Parent Vessel Thrombosis
parent vessel arteries in which thrombosis was documented by an angiogram
Time frame: 6 & 12 Months
Incidence of Parent Vessel Stenosis
parent vessel arteries in which stenosis was documented by an angiogram,
Time frame: 6 & 12 Months
Incidence of Stent Movement/Migration
parent artery in which CODMAN Enterprise® 2 migration was documented from the index procedure until completion of the follow-up visit.
Time frame: 6 & 12 Months
Frequency of Adverse Events
Occurence of any AE related to device/procedure/disease
Time frame: 6 & 12 Months