AneurysmNCT03853070
Post Market Clinical Follow-Up for ED Coil / Electro-detach Generator v4
An observational study of Aneurysm and Arteriovenous Malformations, run by Kaneka Corporation at 3 sites in 2 countries.
Trial summary
This is a multicenter post-marketing clinical follow-up study to collect safety and performance data in a prospective cohort of patients who will have undergone coil embolization using the ED Coil and ED Detach Generator v4. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aneurysm, Arteriovenous Malformations, Arterio-venous Fistula
- What is being tested?
- ED Coil / Electro-detach Generator v4
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 11 Dec 2018to Dec 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients with an aneurysm, arteriovenous malformation, or arteriovenous fistula and eligible for endovascular treatment with ED Coil and ED Detach Generator v4.
Who may be able to join
- Patients are over 18 years of age.
- Patients will undergo catheter embolization using the Kaneka ED Coil with the ED Detach Generator v4 for aneurysm, arteriovenous malformation (AVM), or arteriovenous fistula (AFV)
- The patient, or his/her representative, has agreed to the informed consent.
Who cannot join
- The patient, or his/her representative, is unwilling or unable to agree to the informed consent.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Germany2 sites, 2 recruiting
- Recruiting
Knappschaftskrankenhaus Bochum
Bochum, North Rhine-Westphalia, 44892
Fischer, 02342993801, sebastian.fischer@kk-bochum.de
Sebastian Fischer
- Recruiting
Universitätsklinikum Schleswig-Holstein
Lübeck, Schleswig-Holstein, 23538
Schramm, 045150017215, Ramona.Schramm@uksh.de
Peter Schramm
Belgium1 site, 1 recruiting
- Not yet recruiting
UZA Atwerp
Edegem, Antwerp, 2650
Voormolen, 038214848, Maurits.Voormolen@uza.be
Maurits Voormolen
About this study
This is a multicenter post-marketing clinical follow-up study to collect safety and performance data in a prospective cohort of patients who will have undergone coil embolization using the ED Coil and ED Detach Generator v4.
- Being tested
- ED Coil / Electro-detach Generator v4
- Medical subject headings
- Aneurysm, Arteriovenous Malformations, Arteriovenous Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ED Coil / Electro-detach Generator v4Device
The ED Coil is used for vascular embolization with a platinum coil at the target lesion in a patient's blood vessel. The ED Detach Generator is intended to for use solely to detach the platinum coil from the delivery catheter of the ED Coil.
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance Measure
The recanalization in aneurysms will be classified using the Raymond-Roy Classification. The outcomes following embolization of arteriovenous malformations and arteriovenous fistula will be classified as follows complete occlusion/subtotal occlusion/ partial occlusion
Measured: At 6 months
Performance Measure
The recanalization in aneurysms will be classified using the Raymond-Roy Classification. The outcomes following embolization of arteriovenous malformations and arteriovenous fistula will be classified as follows complete occlusion/subtotal occlusion/ partial occlusion
Measured: At 12 months
Safety Measure - Assessment of Adverse Events
All adverse events will be recorded, along with their seriousness and relatedness to the device or the procedure.
Measured: During 12 months
Technical Measure
The technical properties of the ED Electrodetach Generator v4 will be assessed by successful coil detachment (yes/no)
Measured: At embolization procedure, an average of 1 week
Technical Measure
The technical properties of the ED Electrodetach Generator v4 will be assessed by the the number of detachment attempts
Measured: At embolization procedure, an average of 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2019
- Study start11 Dec 2018
- Primary completionDec 2019 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaneka Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ClinSearch
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03853070
- Sponsor's protocol ID
- ED Coil Prosp
- Status last verified
- Feb 2019
- First submitted
- 11 Feb 2019
- Last updated
- 25 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Market Clinical Follow-Up for ED Coil / Electro-detach Generator v4
- ClinicalTrials.gov ID
- NCT03853070
- Acronym / sponsor ID
- ED Coil Prosp
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Kaneka CorporationIndustry (pharma, biotech, devices)
- Collaborators
- ClinSearch
- Study start
- 11 Dec 2018 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 25 Feb 2019 (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 is a multicenter post-marketing clinical follow-up study to collect safety and performance data in a prospective cohort of patients who will have undergone coil embolization using the ED Coil and ED Detach Generator v4.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with an aneurysm, arteriovenous malformation, or arteriovenous fistula and eligible for endovascular treatment with ED Coil and ED Detach Generator v4.
Key inclusion criteria (3 listed)
- Patients are over 18 years of age.
- Patients will undergo catheter embolization using the Kaneka ED Coil with the ED Detach Generator v4 for aneurysm, arteriovenous malformation (AVM), or arteriovenous fistula (AFV)
- The patient, or his/her representative, has agreed to the informed consent.
Key exclusion criteria (1 listed)
- The patient, or his/her representative, is unwilling or unable to agree to the informed consent.
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 |
|---|---|---|
| ED Coil / Electro-detach Generator v4The ED Coil is used for vascular embolization with a platinum coil at the target lesion in a patient's blood vessel. The ED Detach Generator is intended to for use solely to detach the platinum coil from the delivery catheter of the ED Coil. | Device | – |
Primary outcome
Performance Measure
Time frame: At 6 months
The recanalization in aneurysms will be classified using the Raymond-Roy Classification. The outcomes following embolization of arteriovenous malformations and arteriovenous fistula will be classified as follows complete occlusion/subtotal occlusion/ partial occlusion
Performance Measure
Time frame: At 12 months
The recanalization in aneurysms will be classified using the Raymond-Roy Classification. The outcomes following embolization of arteriovenous malformations and arteriovenous fistula will be classified as follows complete occlusion/subtotal occlusion/ partial occlusion
Safety Measure - Assessment of Adverse Events
Time frame: During 12 months
All adverse events will be recorded, along with their seriousness and relatedness to the device or the procedure.
Technical Measure
Time frame: At embolization procedure, an average of 1 week
The technical properties of the ED Electrodetach Generator v4 will be assessed by successful coil detachment (yes/no)
Technical Measure
Time frame: At embolization procedure, an average of 1 week
The technical properties of the ED Electrodetach Generator v4 will be assessed by the the number of detachment attempts
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2019.
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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.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aneurysm and Arteriovenous Malformations, run by Kaneka Corporation at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany, Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance Measure (time frame: At 6 months). The study lists 5 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 25 Feb 2019.