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

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 Overview

• Status: Completed
• Conditions: Intracranial Aneurysm
• Intervention / Treatment: Device: CascadeTM, Non-Occlusive Remodeling Net

• Study Type: Observational
• Enrollment (Actual): 112

Contacts and Locations

Study Locations

• Bulgaria
  • Sofia, Bulgaria
    • UH St. Ivan Rilski
• Germany
  • Magdeburg, Germany, 39120
    • Medical Faculty of the Otto von Guericke University Magdeburg
  • Solingen, Germany
    • radprax MVZ GmbH
• Israel
  • Tel HaShomer, Israel
    • Sheba Medical Center
• Poland
  • Warsaw, Poland
    • Central Clinical Hospital of the MSWiA
• Spain
  • Barcelona, Spain
    • Hospital Universitari Vall d'Hebron
  • Barcelona, Spain
    • Hospital Universitari de Bellvitge

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who were planned to undergo, or underwent coil embolization procedure of intracranial aneurysms assisted by the Cascade device

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Perflow Medical

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2020
• Primary Completion (Actual): November 3, 2021
• Study Completion (Actual): April 24, 2022

Study Registration Dates

• First Submitted: February 15, 2021
• First Submitted That Met QC Criteria: February 15, 2021
• First Posted (Actual): February 18, 2021

Study Record Updates

• Last Update Posted (Actual): October 4, 2022
• Last Update Submitted That Met QC Criteria: October 2, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: CD0231

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No