Clinical trial NCT02415010: 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Intracranial Aneurysm
Lead sponsor: Cerenovus, Part of DePuy Synthes Products, Inc.
Sponsor class: INDUSTRY
First posted: 2015-04-14
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects with both ruptured and non-ruptured aneurysms will be enrolled into the study, with a parent vessel diameter of ≥ 2.0 mm and ≤ 4 mm

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Major Ipsilateral Stroke and/or Death due to related neurological event in subjects with a non-ruptured aneurysm.
timeFrame: 6 months
Secondary outcomes:
measure: Incidence of Successful Aneurysm treatment without retreatment
timeFrame: 6 Months
measure: Incidence of Successful Aneurysm treatment
timeFrame: 12 months
measure: Incidence of Aneurysm Recanalization
timeFrame: 6 & 12 Months
measure: Incidence of Retreatment
timeFrame: 6 & 12 Months
measure: Incidence of New Neurological Deficits
timeFrame: 30 Days, 6 & 12 Months
measure: Incidence of Major Ipsilateral Stroke and/or Death due to related neurological event
timeFrame: 30 Days and 12 Months
measure: Incidence of Parent Vessel Thrombosis
timeFrame: 6 & 12 Months
measure: Incidence of Parent Vessel Stenosis
timeFrame: 6 & 12 Months
measure: Incidence of Stent Movement/Migration
timeFrame: 6 & 12 Months
measure: Frequency of Adverse Events
timeFrame: 6 & 12 Months
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Helios Klinikum Berlin
city: Bochum
country: Germany
facility: Universitätslklinikum der Ruhr Universität Bochum
city: Eppendorf
country: Germany
facility: Universitätsklinikum Hamburg Eppendorf
city: Hamburg
country: Germany
facility: Asklepios Klinik Atona
city: Lübeck
country: Germany
facility: Universitätsklinikum Schl.-Holst. Campus Lübeck
city: Pamplona
country: Spain
facility: Hospital Universitario de Navarra
city: Bern
country: Switzerland
facility: Inselspital-Universitätsspital Bern
city: Genève
country: Switzerland
facility: Hôpitaux Universitaires de Genève
city: Leeds
country: United Kingdom
facility: Spire Leeds Hospital
city: Romford
country: United Kingdom
facility: Queen's Hospital of Romford
Study officials:
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: J FIEHLER, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References: