Cascade Clinical Data Collection Protocol

Intracranial Aneurysm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04760925
• Other study ID #: CD0231
• Status: Completed
• Start date: March 5, 2020
• Est. completion date: April 24, 2022

Study information

• Verified date: October 2022
• Source: Perflow Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: April 24, 2022
• Est. primary completion date: November 3, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm

Intervention

Device:
• CascadeTM, Non-Occlusive Remodeling Net
Temporary assistance device for coil embolization of intracranial aneurysms

Locations

Country	Name	City	State
Bulgaria	UH St. Ivan Rilski	Sofia
Germany	Medical Faculty of the Otto von Guericke University Magdeburg	Magdeburg
Germany	radprax MVZ GmbH	Solingen
Israel	Sheba Medical Center	Tel HaShomer
Poland	Central Clinical Hospital of the MSWiA	Warsaw
Spain	Hospital Universitari De Bellvitge	Barcelona
Spain	Hospital Universitari Vall D'Hebron	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Perflow Medical

Countries where clinical trial is conducted

Bulgaria,  Germany,  Israel,  Poland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Primary	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: 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	within 30 days post procedure
Secondary	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