Clinical Trial Radar

Morbi-mortality

Morbi-mortality will be defined by a modified Rankin Scale (mRS) ≥ 3 in patients with an mRS ≤ 2 prior to the procedure, or at least 1-point increase over the initial mRS score in subjects with an mRS \> 2 prior to the procedure. The scale runs from 0-6 and is presented as below: 0 - No symptoms. 1. \- No significant disability. Able to carry out all usual activities, despite some symptoms. 2. \- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. \- Moderate disability. Requires some help, but able to walk unassisted. 4. \- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. \- Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. \- Dead

Morbi-mortality related to the device/procedure will be assessed at 365 days, in alignment with the standard of care of the participating sites.

Performance - Aneurysm Occlusion Rate

Assessment of the performance of devices in the light of relevant state-of-the-art performance measures: Complete occlusion rate assessed by Core Lab with Raymond-Roy occlusion classification.

The performance outcomes is assessed at the end of the procedure and at 12 months (± 6 months) in alignment with the standard of care of participating sites.

Performance - Incidence of Aneurysm Re-canalization/ Recurrence/ Regrowth

Assessment of the performance of devices in the light of relevant state-of-the-art performance measures: Incidence of re-canalization/ recurrence/ regrowth compared to procedural outcome assessed by Core Lab.

The performance outcomes are collected at relevant time-points (e.g., 180 days, 365 days, annually up to 5 years post-procedure), in alignment with the standard of care of participating sites.

Performance - Aneurysm Re-treatment Rate

Assessment of the performance of devices in the light of relevant state-of-the-art performance measures: Re-treatment Rate as per investigator's reported data.

The performance outcomes are collected at relevant time-points (e.g., 180 days, 365 days, annually up to 5 years post-procedure), in alignment with the standard of care of participating sites.

Performance - Vascular dissections sealing

Assessment of the performance of devices in the light of relevant state-of-the-art performance measures: Complete sealing of the vascular dissection assessed by Core Lab.

The performance outcomes is assessed at the end of the procedure and at 12 months (± 6 months) in alignment with the standard of care of participating sites.

Performance - Vascular perforation sealing

Assessment of the performance of devices in the light of relevant state-of-the-art performance measures: Complete sealing of the vascular perforation assessed by Core Lab.

The performance outcomes is assessed at the end of the procedure and at 12 months (± 6 months) in alignment with the standard of care of participating sites.

Performance - Arteriovenous fistula (AVF) Occlusion Status

Assessment of the performance of devices in the light of relevant state-of-the-art performance measures: AVF Occlusion status assessed by Core Lab - binary evaluation.

The performance outcomes is assessed at the end of the procedure at early stage post procedure (5 ± 2 months) and at 12 months (± 6 months) in alignment with the standard of care of participating sites.

Performance - Incidence of In-stent Stenosis

Assessment of the performance of devices in the light of relevant state-of-the-art performance measures: Incidence of in-stent stenosis assessed by Core Lab for Neurovascular Flow Diverters and Neurovascular Stent Systems.

The performance outcomes is assessed at 12 months (± 6 months) in alignment with the standard of care of participating sites.

Performance - Device Technical Success

Device Technical success is assessed for each target registry device as per Investigator reported data and defined as successful delivery, positioning, and deployment of the device(s) at the intended target lesion(s).

Device Technical Success is assessed at the end of the procedure.

Safety - Incidence of hemorrhagic, thromboembolic, neurological, or other procedural complications

Occurrence of hemorrhagic, thromboembolic, neurological, or other procedural complication (including technical complications that are not device deficiencies) are evaluated as a secondary safety outcome.

Assessed at relevant time-points (e.g., periprocedural, 180 days, 365 days, annually up to 5 years post-procedure) in alignment with the standard of care of participating sites.

Safety - Rate of Major Strokes and Neurological Death

Rate of major strokes (ischemic or hemorrhagic) or neurological death related to treatment of the target indication are evaluated as a secondary safety outcome.

Depending on the standard of care of the participating sites, e.g. 180 days, 365 days or annually up to 5 years post-procedure.

Safety - Incidence of Device deficiencies

Reported Device deficiencies are evaluated as an additional secondary safety outcome.

Assessed periprocedural and at relevant time-points (e.g., 180 days, 365 days, annually up to 5 years post-procedure) in alignment with the standard of care of participating sites.

Usability

Device usability indicator defined upon key functionalities of each device, as well as understanding and handling by the user are evaluated as a Secondary Usability Outcome. Device key functionalities will be assessed with a 5 grade scale as below: * Excellent * Good * Acceptable * Unsatisfactory * Unable to complete

During the procedure

Performance - Average residual stenosis

Assessment of the performance of devices in the light of relevant state-of-the-art performance measures: Average residual stenosis assessed by Core Lab by Warfarin-Aspirin Symptomatic Intracranial Disease (WASID) method.

The performance outcomes is assessed at 12 months (± 6 months) in alignment with the standard of care of participating sites.