DNX090_Contour
Research type
Research Study
Full title
Post Market Clinical Follow-Up (PMCF) Study of the Contour Neurovascular System (tm)
IRAS ID
289562
Contact name
Tufail Patankar
Contact email
Sponsor organisation
Cerus Endovascular
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 9 months, 0 days
Research summary
This study is a post-market enter study designed to evaluate the safety and performance of Contour Neurovascular System™ in normal medical treatment of intra-cranial aneurysms (brain aneurysms that occur at a vessel bifurcations). The study will include up to 30 adult subjects treated at up to ten (10) different centers in Europe. Study treatment will only be offered to patients who meet the study eligibility criteria and who voluntarily consent to participate. Enrollment and treatment of 30 subjects is expected to take approximately six (6) months. Study subjects will undergo routine pre-procedure examinations and diagnostic imaging. Trained physicians will select an appropriately sized Contour implant that is delivered to the target IA using standard endovascular techniques to occlude blood flow to the aneurysm sac. Subjects will receive routine care and follow-up until reaching the primary study endpoint at approximately 1 year post-procedure. Study participation is complete following the 1 year follow-up examination.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
21/YH/0145
Date of REC Opinion
9 Jul 2021
REC opinion
Favourable Opinion