SUNRISE2
Research type
Research Study
Full 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 Protocol # NV-PMK-1401
IRAS ID
173486
Contact name
Pamela Pitzer
Contact email
Sponsor organisation
Codman Neuro, a division of DePuy Orthopaedics, Inc
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 2 months, 31 days
Research summary
This research, requested by the British Standards Institution (BSI) and part of the Sponsor Company's post-market program, is being conducted to gather information on the Codman Enterprise® 2 Vascular Reconstruction Device. This is a medical device that is marketed for use in treatment of patients with ruptured or non-ruptured intracranial (within the brain) wide-neck aneurysms (a local swelling of an artery). The treatment procedure is known as endovascular stent-assisted coil embolization.
The Codman Enterprise® 2 Vascular Reconstruction Device a stent. It is not experimental and it was granted a CE mark by the BSI in November 2014 on condition that this study is conducted. The Codman Enterprise® 2 device is the next generation of the Codman Enterprise VRD device that has been implanted since 2003. Differences between the 2 devices are minimal. Surgical treatment with the device will be as per the standard practice at the hospital.
The research is being conducted as part of the Study Sponsor's commitment to continually monitor the safety and performance of this device after it has been placed on the market for use. This data, if conclusive, will be used by the Study Sponsor to support renewal processes that are required in order to maintain the CE mark on the product and therefore to continue to allow this device to be available for use. The data may also be submitted to the FDA in the US.The study is being conducted within neuroradiology departments in approximately 12 hospitals within Europe. 50 patients, aged ≥ 18 will participate in the study for 1 year following their initial treatment with the device. Patients will be expected to undergo imaging examinations (2D/3D-Digital Subtraction Angiograpy and Magnetic Resonance Angiography), neurological examinations and complete Patient Questionnaires (EQ-5D). Some assessments performed may be additional to Standard Care provided at the participating hospitals.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
15/YH/0225
Date of REC Opinion
21 May 2015
REC opinion
Favourable Opinion