To date the standard non-surgical treatment strategy for treating un-ruptured intracranial aneurysms is the use of either coils or self-expandable stents. This post-market clinical investigation compares the efficacy of using the CE-marked, commercially available SILK Artery Reconstruction Device against commercially available intracranial coils in the endovascular treatment (occlusion) of intracranial aneurysms.
To date the standard non-surgical treatment strategy for treating un-ruptured intracranial aneurysms is the use of either coils or self-expandable stents. The flow diverter stent concept is based upon the hemodynamic exclusion of the aneurysm sac, without coils being eventually placed within the sac. The primary objective of this post-market clinical investigation is to demonstrate that when using the CE-marked, commercially available SILK Artery Reconstruction Device in the indication for which it is approved, notably for the treatment (occlusion) of intracranial aneurysms, the anatomical results are superior compared to standard treatment with commercially available intracranial coils (used with eventual balloon remodeling and/or stents when necessary). It is a prospective, randomized, unblinded, multi-center post-market clinical investigation. The patient population comprises a maximum of 160 subjects with at least one documented untreated, unruptured intracranial aneurysm suitable for occlusion with an intracranial device. Subject enrollment will require a maximum of 18 months. Enrolled subjects will be followed for 12 months after treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
160
Endovascular treatment with the SILK Artery Reconstruction Device for occluding intracranial aneurysms.
Endovascular treatment with commercially available intracranial coils for occluding intracranial aneurysms.
Universitätsklinikum Würzburg; Abteilung für Neuroradiologie
Würzburg, Germany
RECRUITINGEfficacy
The primary objective is to demonstrate that when using the SILK Artery Reconstruction Device in the indication for which it is approved, notably for the treatment (occlusion) of intracranial aneurysms, the anatomical results are superior compared to standard treatment with commercially available intracranial coils. Therefore, angiographic assessment will measure efficacy by determining the percentage of subjects in each of the two arms experiencing complete occlusion of the aneurysm at 12 months post-procedure.
Time frame: 12 months
Safety
Safety will be evaluated as follows: 1. Peri-procedural ischemic and hemorrhagic adverse events 2. Peri-procedural technical complications 3. Death from any cause 4. Neurological deterioration 5. Cranial nerve deficit 6. General adverse events In addition, Subject Quality of Life (QOL) will be measured at baseline and at 12 months post-procedure using the EuroQol questionnaire.
Time frame: 12 months
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