Post-Market Clinical Follow-Up Study to Confirm Clinical Performance and Safety of the Codman Enterprise® 2 Vascular Reconstruction Device in the Endovascular Treatment of Intracranial Aneurysms

Study Overview
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Brief Summary
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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.

Official Title
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A Post-Market Clinical Follow-Up Study to Confirm Clinical Performance and Safety of the Codman Enterprise® 2 Vascular Reconstruction Device in the Endovascular Treatment of Intracranial Aneurysms

Conditions
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Intracranial Aneurysm

Intervention / Treatment
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* Device: Enterprise 2 Vascular Reconstruction Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject ≥ 18 years old. Subjects with non-ruptured or ruptured intracranial aneurysm that is referred for endovascular treatment. Parent vessel with a diameter of ≥ 2.0 mm and ≤ 4 mm. Subject understands the nature of the procedure and provides voluntary written informed consent in accordance with the requirements of this study protocol. Subject is willing to participate in the telephone follow-ups and to return to the investigational site for the post-procedure follow-up evaluations. Exclusion Criteria: Angiogram demonstrating that the aneurysm is not appropriate for endovascular treatment (i.e.: severe intracranial vessel tortuosity, stenosis, intracranial vasospasm not responsive to medical therapy). Mycotic or traumatic aneurysm. Arteriovenous malformation (AVM) in the territory of the target aneurysm. Two or more aneurysms (>2mm) in associated distribution. Hunt and Hess Scale (HHS) of IV or V at inclusion for subject with ruptured aneurysms. Life expectancy of less than 6 months as determined by the treating physician. A planned staged procedure (i.e. a procedure where entire treatment with the devices (e.g. coils/stents) is completed over separate sessions). Previous neuro-interventional or neuro-surgical procedure of any kind within 30 days prior to the study procedure. Intracranial mass (tumor, abscess, or other infection), or undergoing radiation therapy for carcinoma or sarcoma of the head or neck region. Unsuitable for the antithrombotic and/or anticoagulant therapies Serum creatinine level > 2.5 mg/dl within 7 days prior to index procedure Known hypersensitivity or allergies to cobalt, nitinol metal, nickel, or sensitivity to contrast media, Evidence of an acute myocardial infarction (MI) within 30 days prior to the index procedure. Uncontrolled atrial fibrillation or known cardiac disorders likely to be associated with cardioembolic symptoms. Subject is pregnant

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Enterprise 2 Vascular Reconstruction Device|Stenting Assisted coiling procedure|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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 | 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 | 30 Days and 12 Months | 
| Incidence of Parent Vessel Thrombosis | parent vessel arteries in which thrombosis was documented by an angiogram | 6 & 12 Months | 
| Incidence of Parent Vessel Stenosis | parent vessel arteries in which stenosis was documented by an angiogram, | 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. | 6 & 12 Months | 
| Frequency of Adverse Events | Occurence of any AE related to device/procedure/disease | 6 & 12 Months |