Intracranial Aneurysm
Conditions
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.
Interventions
DEVICECascadeTM, Non-Occlusive Remodeling Net
Temporary assistance device for coil embolization of intracranial aneurysms
Sponsors
Perflow Medical
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
Patients must fulfill the following eligibility criteria to be included in the study: 1. Patient has been treated or planned to be treated with Cascade (Cascade device was opened). 2. 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. 3. Coil embolization procedure of intracranial aneurysm using temporary assisting device is initiated
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Efficacy Endpoint - Successful coil embolization of the target intracranial aneurysm assisted by Cascade device | During procedure | 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 |
| Main Safety Endpoint - Incidence of Serious Adverse Device Effects (SADE) | within 30 days post procedure | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Efficacy Endpoint - Maintenance or improvement of aneurysm occlusion | 3-6 months post procedure | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Other Safety Endpoint - Incidence of all Adverse Events | 30 days post procedure | All adverse events experienced by enrolled patients within 30 days post coil embolization procedure, regardless of relatedness to the Cascade device or the coil embolization procedure |
Countries
Bulgaria, Germany, Israel, Poland, Spain
Outcome results
None listed