Cerebral Arteriovenous MalformationsNCT02602990
Treatment of Cerebral Arteriovenous Malformations With SQUID™ Liquid Embolic Agent
An observational study of Cerebral Arteriovenous Malformations, run by Emboflu at 6 sites in 2 countries.
Trial summary
A non-interventional multicentric study for patients with a cerebral AVM for which endovascular treatment is indicated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Arteriovenous Malformations
- What is being tested?
- SQUID™
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Aug 2015to May 2019
- How long will I take part?
- 6 Months
- 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: Patients with a cerebral AVM for whom endovascular treatment is indicated.
Who may be able to join
- Patient must sign the informed consent form prior to the index-procedure. If patient is unable to provide it him- or herself because of the patient's medical condition, the informed consent of the patient's legally authorized representative shall be requested.
- The patient has an untreated or endovascular previously treated cerebral AVM for which endovascular treatment is indicated.
- The patient is at least 18 years old.
Who cannot join
- Patient is pregnant.
- Patient with renal insufficiency (GFR < 45 ml/min/1.73 m²)
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Belgium5 sites
UZ Antwerpen
Edegem, 2650
Ziekenhuis Oost Limburg (ZOL)
Genk, 3600
AZ Sint-Lucas
Ghent, 9000
AZ Groeninge
Kortrijk, 8500
UZ Leuven
Leuven, 3000
About this study
A non-interventional multicentric study for patients with a cerebral AVM for which endovascular treatment is indicated.
Read the detailed description
This observational study will collect data about the treatment of ruptured, unruptured, untreated or endovascular previously treated AVM's.
Primary endpoint is safety. Safety will be assessed with the number of procedure-related complications occurring during the endovascular treatment until 30 days after the final embolization.
Secondary endpoint is efficacy. Efficacy will be assessed by angiography and clinical outcome assessments (mRS).
For each patient enrolled, data will be collected at inclusion, at each embolization session and at 6 ± 1 months after the end of the endovascular treatment phase.
- Conditions
- Cerebral Arteriovenous Malformations
- Being tested
- SQUID™
- Keywords
- Cerebral, Arteriovenous, Malformation, Embolization, Endovascular
- Medical subject headings
- Intracranial Arteriovenous Malformations, Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SQUID™Device
| Study group | Role | What they receive |
|---|---|---|
| Cerebral AVM treated with SQUID™ | Not described Receives: Device: SQUID™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of complications / adverse events (Safety)
The safety is assessed with the number of procedure-related complications occurring during endovascular treatment until 30 days after the final embolization session. Procedure-related complications include complications/adverse events related to the procedure or to the device such as but not limited to hemorrhagic and ischemic complications.
Measured: From the start of the procedure until 30 days after procedure
Secondary outcomes (2)
Clinical outcome measurement with mRS (Efficacy)
Change of mRS score at 6 months after treatment phase is assessed compared to baseline mRS score.
Measured: At 6 months after the last treatment session, compared to baseline
Degree of targeted portion of AVM occlusion
The degree of the predefined targeted portion of the AVM's occlusion will be assessed angiographically.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2015 (estimated)
- Study startAug 2015
- Primary completionMay 2019
- Study completionMay 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Arteriovenous MalformationsStudies 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
- 50 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Emboflu
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Archer Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02602990
- Sponsor's protocol ID
- SQUID
- Status last verified
- Sep 2019
- First submitted
- 6 Nov 2015
- Last updated
- 20 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Cerebral Arteriovenous Malformations With SQUID™ Liquid Embolic Agent
- ClinicalTrials.gov ID
- NCT02602990
- Acronym / sponsor ID
- SQUID
- Conditions
- Cerebral Arteriovenous Malformations
- Keywords
- Cerebral, Arteriovenous, Malformation, Embolization, Endovascular
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- EmbofluIndustry (pharma, biotech, devices)
- Collaborators
- Archer Research
- Study start
- Aug 2015 (actual)
- Primary completion
- May 2019 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 11 Nov 2015 (estimated)
- 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.
A non-interventional multicentric study for patients with a cerebral AVM for which endovascular treatment is indicated.
Detailed description
This observational study will collect data about the treatment of ruptured, unruptured, untreated or endovascular previously treated AVM's.
Primary endpoint is safety. Safety will be assessed with the number of procedure-related complications occurring during the endovascular treatment until 30 days after the final embolization.
Secondary endpoint is efficacy. Efficacy will be assessed by angiography and clinical outcome assessments (mRS).
For each patient enrolled, data will be collected at inclusion, at each embolization session and at 6 ± 1 months after the end of the endovascular treatment phase.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cerebral AVM treated with SQUID™ | – | Device: SQUID™ |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a cerebral AVM for whom endovascular treatment is indicated.
Key inclusion criteria (3 listed)
- Patient must sign the informed consent form prior to the index-procedure. If patient is unable to provide it him- or herself because of the patient's medical condition, the informed consent of the patient's legally authorized representative shall be requested.
- The patient has an untreated or endovascular previously treated cerebral AVM for which endovascular treatment is indicated.
- The patient is at least 18 years old.
Key exclusion criteria (2 listed)
- Patient is pregnant.
- Patient with renal insufficiency (GFR < 45 ml/min/1.73 m²)
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 |
|---|---|---|
| SQUID™ | Device | Cerebral AVM treated with SQUID™ |
Primary outcome
Incidence of complications / adverse events (Safety)
Time frame: From the start of the procedure until 30 days after procedure
The safety is assessed with the number of procedure-related complications occurring during endovascular treatment until 30 days after the final embolization session. Procedure-related complications include complications/adverse events related to the procedure or to the device such as but not limited to hemorrhagic and ischemic complications.
2 secondary outcomes
Clinical outcome measurement with mRS (Efficacy)
Time frame: At 6 months after the last treatment session, compared to baseline
Degree of targeted portion of AVM occlusion
Time frame: 6 months
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 20 Sep 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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Arteriovenous Malformations, run by Emboflu at 6 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 2 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: finished, as of the sponsor's last update on 20 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Belgium, Germany. 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?
Incidence of complications / adverse events (Safety) (time frame: From the start of the procedure until 30 days after procedure). 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 20 Sep 2019.