CNV_2017_01 STERLING
Research type
Research Study
Full title
A Prospective, Multi-Center, Single Arm Study to obtain “real world” clinical data and characterize the acute and long term performance of the MICRUSFRAME and GALAXY coils including the PulseRider Aneurysm Neck Reconstruction Device for the endovascular treatment of intracranial aneurysms.
IRAS ID
287747
Contact name
Eugenia Mc Allister
Contact email
Sponsor organisation
Cerenovus
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 7 months, 1 days
Research summary
The study is a post-market registry.The objective of this study is to obtain “real world” clinical data and characterize the acute and long-term performance of the MICRUSFRAME and GALAXY coils for the endovascular treatment of intracranial aneurysms.
The secondary objective of this study is to evaluate “real world” outcomes with the use of the PulseRider Aneurysm Neck Reconstruction device for the endovascular treatment of intracranial aneurysms.
The patient with ruptured and unruptured aneurisms that meet inclusion/exclusion criteria are eligible for the study.
All the procedures of the study must be a standard of care at the selected sites.
The study duration is expected to be approximately 6 years (including enrollment phase). The enrollment phase is expected to take approximately 5 years following enrollment of the first subject.
It will take each participant approximately 1 year to complete the protocol required follow-up visits.REC name
Yorkshire & The Humber - South Yorkshire Research Ethics Committee
REC reference
21/YH/0166
Date of REC Opinion
5 Aug 2021
REC opinion
Unfavourable Opinion