COATING
Research type
Research Study
Full title
Coating to Optimize Aneurysm Treatment In The New Flow Diverter Generation
IRAS ID
297197
Contact name
Saleh M Lamin
Contact email
Sponsor organisation
phenox GmbH
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
This is an international, multi-site randomized controlled trial.
The objective of this study is to evaluate the efficacy of the p64 MW Flow Modulation Device (HPC) in the treatment of intracranial aneurysms.
The objective is to enroll 170 patients in maximum 25 European institutions. The expected study duration is 36 months, 12 months per patient.
Male and female patients aged 18 years and older for whom the the medical team concludes that a flow modulation device would be benefic for the treatment of their intracranial aneurysm, would be eligible.
Approximately 2 days after the implantation of the device and before leaving the hospital the patient will undergo magnetic resonance imaging (i.e. an MRI). An MRI is a medical imaging technique that provides detailed images of your brain.
The patient has to return to the hospital 2-3 times for follow-up monitoring, as it is the case for all patients treated for an intracranial aneurysm, even for those not enrolled in this clinical study.REC name
West of Scotland REC 3
REC reference
22/WS/0039
Date of REC Opinion
6 Jun 2022
REC opinion
Further Information Favourable Opinion