NCT04760925

Cascade Clinical Data Collection Protocol

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 112 (actual)
• Sponsor: Perflow Medical · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Intracranial Aneurysm

Interventions

Type	Name	Description
DEVICE	CascadeTM, Non-Occlusive Remodeling Net	Temporary assistance device for coil embolization of intracranial aneurysms

Timeline

• Start date: 2020-03-05
• Primary completion: 2021-11-03
• Completion: 2022-04-24
• First posted: 2021-02-18
• Last updated: 2022-10-04

Locations

7 sites across 5 countries: Bulgaria, Germany, Israel, Poland, Spain