EESIS
Research type
Research Study
Full title
A multi-center post marketing study evaluating the safety, technical feasibility, and efficacy of the eCLIPsTM Family of Products for the treatment of bifurcation intracranial aneurysms.
IRAS ID
200575
Contact name
Joost de Vries
Contact email
Sponsor organisation
EVASC
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Summary of Research
Few licensed devices are available in Europe for the endoluminal (within the lumen/artery) treatment of bifurcation intracranial aneurysms, all in early stages of clinical evaluation. Evasc Medical Systems Corp. has developed an endovascular device specifically intended for use in conjunction with coils for the treatment of intracranial aneurysms arising at bifurcations. The eCLIPsTM Products are designed to address clinical need for the treatment of bifurcation aneurysms.This study is An open label, prospective, multi center, single-arm, post marketing study evaluating the safety, technical feasibility, and efficacy of the eCLIPs™ Family of Products for the treatment of bifurcation intracranial aneurysms.
The objective of the study is to provide preliminary technical feasibility, safety and efficacy data for eCLIPs Family of products.In total 60 patients will be enrolled and participate for 12 months in the study. In addition to the standard of care procedure one additional MRI-scan will be performed and an extra neurological examination after 12 months.
The participating countries are: UK, The Netherlands, Denmark, France, Italy, Germany, Austria.Summary of Results
Please see publication. Please note no British patients have been included.REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
16/EE/0491
Date of REC Opinion
26 Jan 2017
REC opinion
Further Information Favourable Opinion