Cascade Clinical Data Collection Protocol

Study Overview
=================
Brief Summary
-----------------
This study is a multi-center, single arm, open label, retrospective and prospective clinical data collection of CascadeTM, Non-Occlusive Remodeling Net, in adults with intracranial aneurysms, demonstrating the effectiveness and safety of the CascadeTM in providing temporary assistance for coil embolization of intracranial aneurysms. All consecutive eligible patients from all participating sites will be included in this clinical data collection. The relevant data of the coil embolization procedure will be collected via an eCRF system. Peri procedural data on the coil embolization procedure as well as discharge, 30 days and at 3-6 months status will be collected.

Official Title
-----------------
Single Arm, Open Label, Retrospective and Prospective Clinical Data Collection to Assess CascadeTM, Non-Occlusive Remodeling Net, in Providing Temporary Assistance for Coil Embolization of Intracranial Aneurysms

Conditions
-----------------
Intracranial Aneurysm

Intervention / Treatment
-----------------
* Device: CascadeTM, Non-Occlusive Remodeling Net


Participation Criteria
=================
Eligibility Criteria
-----------------
Patients must fulfill the following eligibility criteria to be included in the study: Patient has been treated or planned to be treated with Cascade (Cascade device was opened). Patient or patient's legally authorized representative or patient's family member (if approved by IEC) has signed and dated an Informed Consent Form (ICF), unless ICF is waived by local IEC. Coil embolization procedure of intracranial aneurysm using temporary assisting device is initiated
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: CascadeTM, Non-Occlusive Remodeling Net|Temporary assistance device for coil embolization of intracranial aneurysms|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Efficacy Endpoint - Successful coil embolization of the target intracranial aneurysm assisted by Cascade device | Successful coil embolization of the target intracranial aneurysm assisted by Cascade device, without coil entanglement, protrusion or prolapse into the parent vessel at the end of the procedure, as evaluated angiographically by a central core-lab | During procedure | 
| Main Safety Endpoint - Incidence of Serious Adverse Device Effects (SADE) | Serious adverse device effects (SADE) occurring within 30 days post procedure, including the following safety events: Vessel damage related to the use of the study device that leads to dissection, perforation, hemorrhage or vasospasm. Thromboembolic event related to the use of the study device. Coil entanglement | within 30 days post procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Efficacy Endpoint - Maintenance or improvement of aneurysm occlusion | Maintenance or improvement of aneurysm occlusion (evaluated angiographically by a central core-lab) using modified Raymond-Roy Classification (MRRC) at 3-6 months compared to the end of the procedure | 3-6 months post procedure |