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NCT Number: NCT04760925

Cascade Clinical Data Collection Protocol

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.

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Key information

Conditions

Intracranial Aneurysm Aneurysm Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Intracranial Arterial Diseases Nervous System Diseases Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

UH St. Ivan Rilski, Sofia, Bulgaria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Patients must fulfill the following eligibility criteria to be included in the study:

  • Patient has been treated or planned to be treated with Cascade (Cascade device was opened).
  • 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.
  • Coil embolization procedure of intracranial aneurysm using temporary assisting device is initiated

Treatment and study plan

CascadeTM, Non-Occlusive Remodeling Net

Device

Temporary assistance device for coil embolization of intracranial aneurysms

Primary outcomes

  1. Primary Efficacy Endpoint - Successful coil embolization of the target intracranial aneurysm assisted by Cascade device

    Time frame: 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

  2. Main Safety Endpoint - Incidence of Serious Adverse Device Effects (SADE)

    Time frame: 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 outcomes

  1. Secondary Efficacy Endpoint - Maintenance or improvement of aneurysm occlusion

    Time frame: 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

Other outcomes

  1. Other Safety Endpoint - Incidence of all Adverse Events

    Time frame: 30 days post procedure

    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

Sponsors and collaborators

Lead sponsor

Perflow Medical

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Feb 18, 2021
Registry last updated
Oct 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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