CorPath® GRX Neuro Study

An Evaluation of Effectiveness and Safety of the CorPath® GRX System in Endovascular Embolization Procedures of Cerebral Aneurysms

The primary objective of this study is to evaluate the effectiveness and safety of robotic-assisted endovascular embolization procedures compared to objective performance criteria for traditional, manual operation based on the scientific literature.

This is a prospective, single-arm, international, multi- center, non-inferiority study to evaluate the effectiveness and safety of the CorPath GRX System for endovascular cerebral aneurysm embolization compared to historical controls. Subject selection requires a clinical indication for endovascular coil and/or stent-assist coiling embolization of cerebral aneurysms.

Inclusion Criteria:

1. Age ≥ 18 years.
2. At least one cerebral aneurysm (unruptured) with indication for endovascular treatment; dome to neck ratio >1.5 or aneurysm neck width >4.0 mm.
3. The Investigator deems the procedure appropriate for both manual or robotic-assisted endovascular treatment.
4. The conscious subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.

Exclusion Criteria:

1. Failure / unwillingness of the subject to provide informed consent, unless the EC has waived informed consent.
2. The Investigator determines that the subject or the neurovascular anatomy is not suitable for robotic-assisted endovascular treatment.
3. Women who are pregnant.
4. Persons under guardianship or curatorship.