Cascade Clinical Data Collection Protocol

Perflow Medical

Status: Completed

Conditions: Intracranial Aneurysm

Treatments: Device: CascadeTM, Non-Occlusive Remodeling Net

Study type: Observational

Funder types: Industry

Identifiers

NCT04760925

CD0231

Details and patient eligibility

About

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.

Enrollment: 112 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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