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

NCT ID: NCT02415010

Last Updated: 2019-12-12

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 26 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-07-01
• Study Completion Date: 2019-06-25

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.

Conditions

Intracranial Aneurysm

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Enterprise 2 Vascular Reconstruction Device

Stenting Assisted coiling procedure

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cerenovus, Part of DePuy Synthes Products, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

J FIEHLER, MD-PhD

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Hamburg-Eppendorf

Locations

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

Geneva, , Switzerland

Spire Leeds Hospital

Leeds, , United Kingdom

Queen's Hospital of Romford

Romford, , United Kingdom

Countries

Germany; Spain; Switzerland; United Kingdom

Other Identifiers

NV-PMK-1401

Identifier Type: -

Identifier Source: org_study_id