Cascade Clinical Data Collection Protocol

Completed

• Conditions: Intracranial Aneurysm

• Registration Number: NCT04760925
• Lead Sponsor: Perflow Medical

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-05
• Study First Submitted: 2021-02-15
• Study First Submitted QC: 2021-02-15
• Study First Posted: 2021-02-18
• Primary Completion: 2021-11-03
• Study Completion: 2022-04-24
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-02
• Last Update Posted: 2022-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (7)

UH St. Ivan Rilski; 🇧🇬 Sofia, Bulgaria

Medical Faculty of the Otto von Guericke University Magdeburg; 🇩🇪 Magdeburg, Germany

radprax MVZ GmbH; 🇩🇪 Solingen, Germany

Sheba Medical Center; 🇮🇱 Tel HaShomer, Israel

Central Clinical Hospital of the MSWiA; 🇵🇱 Warsaw, Poland

Hospital Universitari De Bellvitge; 🇪🇸 Barcelona, Spain

Hospital Universitari Vall D'Hebron; 🇪🇸 Barcelona, Spain