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
NCT02415010 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 26
Last updated 2019-12-12
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
Interventions
- DEVICE
-
Enterprise 2 Vascular Reconstruction Device
Stenting Assisted coiling procedure
Sponsors & Collaborators
-
Cerenovus, Part of DePuy Synthes Products, Inc.
lead INDUSTRY
Principal Investigators
-
J FIEHLER, MD-PhD · Universitätsklinikum Hamburg-Eppendorf
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-07-01
- Primary Completion
- 2019-06-25
- Completion
- 2019-06-25
Countries
- Germany
- Spain
- Switzerland
- United Kingdom
Study Locations
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