Cascade Clinical Data Collection Protocol

October 2, 2022 updated by: Perflow Medical

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
112

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
During procedure
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
within 30 days post procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
3-6 months post procedure

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
30 days post procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Perflow Medical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 5, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 3, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 24, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 15, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 15, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 18, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 4, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 2, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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