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

Terminated

• Conditions: Intracranial Aneurysm

• Registration Number: NCT02415010
• Lead Sponsor: Cerenovus, Part of DePuy Synthes Products, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-04-08
• Study First Submitted QC: 2015-04-08
• Study First Posted: 2015-04-14
• Study Start: 2015-07-01
• Primary Completion: 2019-06-25
• Study Completion: 2019-06-25
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-10
• Last Update Posted: 2019-12-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

1. Subject ≥ 18 years old.
2. Subjects with non-ruptured or ruptured intracranial aneurysm that is referred for endovascular treatment.
3. Parent vessel with a diameter of ≥ 2.0 mm and ≤ 4 mm.
4. Subject understands the nature of the procedure and provides voluntary written informed consent in accordance with the requirements of this study protocol.
5. 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

1. 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).
2. Mycotic or traumatic aneurysm.
3. Arteriovenous malformation (AVM) in the territory of the target aneurysm.
4. Two or more aneurysms (>2mm) in associated distribution.
5. Hunt and Hess Scale (HHS) of IV or V at inclusion for subject with ruptured aneurysms.
6. Life expectancy of less than 6 months as determined by the treating physician.
7. A planned staged procedure (i.e. a procedure where entire treatment with the devices (e.g. coils/stents) is completed over separate sessions).
8. Previous neuro-interventional or neuro-surgical procedure of any kind within 30 days prior to the study procedure.
9. Intracranial mass (tumor, abscess, or other infection), or undergoing radiation therapy for carcinoma or sarcoma of the head or neck region.
10. Unsuitable for the antithrombotic and/or anticoagulant therapies
11. Serum creatinine level > 2.5 mg/dl within 7 days prior to index procedure
12. Known hypersensitivity or allergies to cobalt, nitinol metal, nickel, or sensitivity to contrast media,
13. Evidence of an acute myocardial infarction (MI) within 30 days prior to the index procedure.
14. Uncontrolled atrial fibrillation or known cardiac disorders likely to be associated with cardioembolic symptoms.
15. Subject is pregnant

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of Major Ipsilateral Stroke and/or Death due to related neurological event in subjects with a non-ruptured aneurysm.	6 months	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

Secondary Outcome Measures

Name	Time	Method
Incidence of Successful Aneurysm treatment	12 months	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.
Incidence of Parent Vessel Thrombosis	6 & 12 Months	parent vessel arteries in which thrombosis was documented by an angiogram
Incidence of Successful Aneurysm treatment without retreatment	6 Months	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.
Incidence of Retreatment	6 & 12 Months	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.
Incidence of New Neurological Deficits	30 Days, 6 & 12 Months	subjects who have an increase in mRS greater than 2 from baseline related to stroke or death
Incidence of Major Ipsilateral Stroke and/or Death due to related neurological event	30 Days and 12 Months	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
Incidence of Parent Vessel Stenosis	6 & 12 Months	parent vessel arteries in which stenosis was documented by an angiogram,
Incidence of Aneurysm Recanalization	6 & 12 Months	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.
Incidence of Stent Movement/Migration	6 & 12 Months	parent artery in which CODMAN Enterprise® 2 migration was documented from the index procedure until completion of the follow-up visit.
Frequency of Adverse Events	6 & 12 Months	Occurence of any AE related to device/procedure/disease

Trial Locations

Locations (10)

Helios Klinikum Berlin; 🇩🇪 Berlin, Germany

Universitätslklinikum der Ruhr Universität Bochum; 🇩🇪 Bochum, Germany

Universitätsklinikum Hamburg Eppendorf; 🇩🇪 Eppendorf, Germany

Asklepios Klinik Atona; 🇩🇪 Hamburg, Germany

Universitätsklinikum Schl.-Holst. Campus Lübeck; 🇩🇪 Lübeck, Germany

Hospital Universitario de Navarra; 🇪🇸 Pamplona, Spain

Inselspital-Universitätsspital Bern; 🇨🇭 Bern, Switzerland

Hôpitaux Universitaires de Genève; 🇨🇭 Genève, Switzerland

Spire Leeds Hospital; 🇬🇧 Leeds, United Kingdom

Queen's Hospital of Romford; 🇬🇧 Romford, United Kingdom