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

Cerenovus, Part of DePuy Synthes Products, Inc.10 sites in 4 countries26 target enrollmentJuly 1, 2015

ConditionsIntracranial Aneurysm

Overview

Phase: N/A
Intervention: Not specified
Conditions: Intracranial Aneurysm
Sponsor: Cerenovus, Part of DePuy Synthes Products, Inc.
Enrollment: 26
Locations: 10
Primary Endpoint: Incidence of Major Ipsilateral Stroke and/or Death due to related neurological event in subjects with a non-ruptured aneurysm.
Status: Terminated
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 1, 2015

End Date

June 25, 2019

Last Updated

6 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Cerenovus, Part of DePuy Synthes Products, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: 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 Outcomes

Incidence of Successful Aneurysm treatment(12 months)
Incidence of Parent Vessel Thrombosis(6 & 12 Months)
Incidence of Successful Aneurysm treatment without retreatment(6 Months)
Incidence of Retreatment(6 & 12 Months)
Incidence of New Neurological Deficits(30 Days, 6 & 12 Months)
Incidence of Major Ipsilateral Stroke and/or Death due to related neurological event(30 Days and 12 Months)
Incidence of Parent Vessel Stenosis(6 & 12 Months)
Incidence of Aneurysm Recanalization(6 & 12 Months)
Incidence of Stent Movement/Migration(6 & 12 Months)
Frequency of Adverse Events(6 & 12 Months)