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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CascadeTM, Non-Occlusive Remodeling Net | Device | Temporary assistance device for coil embolization of intracranial aneurysms |
| 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:
| within 30 days post procedure |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Other Safety Endpoint - Incidence of all Adverse Events | 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 | 30 days post procedure |
Patients must fulfill the following eligibility criteria to be included in the study:
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Patients who were planned to undergo, or underwent coil embolization procedure of intracranial aneurysms assisted by the Cascade device
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UH St. Ivan Rilski | Sofia | Bulgaria | ||||
| Medical Faculty of the Otto von Guericke University Magdeburg |
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| ID | Term |
|---|---|
| D002532 | Intracranial Aneurysm |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Magdeburg |
| 39120 |
| Germany |
| radprax MVZ GmbH | Solingen | Germany |
| Sheba Medical Center | Tel Litwinsky | Israel |
| Central Clinical Hospital of the MSWiA | Warsaw | Poland |
| Hospital Universitari De Bellvitge | Barcelona | Spain |
| Hospital Universitari Vall D'Hebron | Barcelona | Spain |
| D009422 | Nervous System Diseases |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |