Cascade Clinical Data Collection Protocol

Perflow Medical112 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

112

Conditions

Intracranial Aneurysm

Interventions

CascadeTM, Non-Occlusive Remodeling NetDEVICE

Temporary assistance device for coil embolization of intracranial aneurysms

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

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 Litwinsky, Israel

Outcomes

Primary Outcomes

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

Time frame: 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: * 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

Time frame: within 30 days post procedure

Secondary Outcomes

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

Time frame: 3-6 months post procedure

Data from ClinicalTrials.gov

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