Cerus Endovascular is sponsoring a prospective, single arm, multi-center study to document the safety and performance of Neqstent in adjunctive therapy. The purpose of the study is to document safety and performance of the Neqstent in adjunctive therapy in treatment for patients with intracranial aneurysms (IA).
Neqstent is designed as an adjunctive therapy for patients with unruptured and failed bifurcation aneurysm embolizations. Neqstent can be positioned at the neck of the aneurysm with or without existing coils and other embolization products. Embolization coils should be added to fill the dome of the aneurysm after placement of Neqstent.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
38
Adjunctive device providing stable aneurysm neck coverage for the placement of embolization coils within the aneurysm sac and long term stable occlusion of the aneurysm.
Christian Doppler Klinikum
Salzburg, Austria
Alberta Health Sciences
Edmonton, Alberta, Canada
Odense University Hospital
Odense, Denmark
UK Hamburg
Hamburg, Germany
The Proportion of Subjects With Death of Any Non-accidental Cause or Any Major Disabling Stroke After Treatment or Major Disabling Stroke or Death Due to Neurological Cause.
Time frame: From day 31 to 6 months after treatment
The Proportion of Subjects With Complete Occlusion
Success will be defined as complete occlusion demonstrated by a Grade 1 using the Raymond Roy Scale.
Time frame: 6 months
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UKSH Kiel
Kiel, Germany
Klinikum der Universität München
Munich, Germany
Inerespital Basel
Basel, Switzerland