Intracranial AneurysmNCT04760925
Cascade Clinical Data Collection Protocol
An observational study of Intracranial Aneurysm, run by Perflow Medical at 7 sites in 5 countries.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Intracranial Aneurysm
- What is being tested?
- CascadeTM, Non-Occlusive Remodeling Net
- Type of treatment
- Medical device
- How many people
- 112 participants
- Where
- 7 sitesin 5 countries
- Study dates
- 5 Mar 2020to 24 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who were planned to undergo, or underwent coil embolization procedure of intracranial aneurysms assisted by the Cascade device
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
Trial locations and contacts
7 sites in 5 countries.
7 sites in 5 countries
Germany2 sites
Medical Faculty of the Otto von Guericke University Magdeburg
Magdeburg, 39120
radprax MVZ GmbH
Solingen
Spain2 sites
Hospital Universitari De Bellvitge
Barcelona
Hospital Universitari Vall D'Hebron
Barcelona
About this study
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
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.
- Conditions
- Intracranial Aneurysm
- Being tested
- CascadeTM, Non-Occlusive Remodeling Net
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CascadeTM, Non-Occlusive Remodeling NetDevice
Temporary assistance device for coil embolization of intracranial aneurysms
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: within 30 days post procedure
Secondary outcomes (1)
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
Measured: 3-6 months post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start5 Mar 2020
- Primary completion3 Nov 2021
- Study completion24 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Perflow Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04760925
- Sponsor's protocol ID
- CD0231
- Status last verified
- Oct 2022
- First submitted
- 15 Feb 2021
- Last updated
- 4 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04760925
- Acronym / sponsor ID
- CD0231
- Conditions
- Intracranial Aneurysm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Perflow MedicalIndustry (pharma, biotech, devices)
- Study start
- 5 Mar 2020 (actual)
- Primary completion
- 3 Nov 2021 (actual)
- Study completion
- 24 Apr 2022 (actual)
- First posted
- 18 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who were planned to undergo, or underwent coil embolization procedure of intracranial aneurysms assisted by the Cascade device
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CascadeTM, Non-Occlusive Remodeling NetTemporary assistance device for coil embolization of intracranial aneurysms | Device | – |
Primary outcome
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
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
1 secondary outcome
Secondary Efficacy Endpoint - Maintenance or improvement of aneurysm occlusion
Time frame: 3-6 months post procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Aneurysm, run by Perflow Medical at 7 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Germany, Spain, Bulgaria, Israel, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Efficacy Endpoint - Successful coil embolization of the target intracranial aneurysm assisted by Cascade device (time frame: During procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2022.