Innovative NeurovaScular Product surveIllance REgistry (INSPIRE)

Brief description of study

The purpose of this study is to collect information over time about how the approved Pipeline™ Shield Device is working and/or the outcome of the treatment. The study will be used to support post-market surveillance activities and post-approval studies (e.g., to collect safety and performance information). In addition, it will be used to obtain clinical evidence for the development and improvement of medical devices, therapies, device guidelines, patient services/solutions and provide clinical data to support health economics and clinical outcomes research. The Pipeline™ Shield Device is not investigational and the procedures being performed are not experimental. The study sponsor is Micro Therapeutics, Inc. d/b/a ev3 Neurovascular (a wholly owned subsidiary of Medtronic/Medtronic, Inc. (“Medtronic”). This product has been approved or cleared by the U.S. Food and Drug Administration (FDA) and is available on the market for use in patients who have a brain aneurysm similar to yours. The Pipeline™ Shield Device is a cylindrical metal mesh that is implanted into the blood vessel across the opening (or ‘neck’) of your brain aneurysm to slow down or stop the blood flow into the aneurysm, causing the blood within the aneurysm to clot. This can help prevent the aneurysm from getting bigger and makes it less likely for the aneurysm to rupture. The Pipeline™ Shield Device also has a surface modification (Shield Technology™) that is chemically bonded to the strands of the device to reduce the likelihood of producing a blood clot when the device is in contact with blood.

Clinical Study Identifier: s21-01163
Principal Investigator: Eytan Raz.
Other Investigator: Vera Sharashidze.

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