Arterial EmbolizationIdealeNCT02863133
Prospective Study to Assess the Safety and Performance of the Easyx Antia Liquid Embolic in Intracranial Interventions
A study testing Liquid Embolic in people with Arterial Embolization, run by Antia Therapeutics AG.
Trial summary
The study is a prospective, multicenter, multinational study to assess the safety and performance of the Easyx (trade name) Antia Liquid Embolic during embolization of intracranial malformations and fistulas. The clinical trial will include patients already scheduled for neuroradiological interventions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arterial Embolization
- What is being tested?
- Liquid Embolic
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- No sites listed yet
- Study dates
- Oct 2016to Oct 2018
- Phase
- Interventional
- 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
Who may be able to join
- Subject is aged 18 years or over
- Subject exhibits a DAVF or BAVM or tumor that has been selected for endovascular treatment
- Subject has provided written consent for the procedure.
- Subject agrees to all follow up visits required by the protocol
- The Subject is clinically and neurologically stable for a minimum of 48 hours prior to embolization.
Who cannot join
- The subject has a brain AVM with high flow arteriovenous fistula that the investigator has determined to be unsuitable for embolization.
- The subject has had acute cerebral bleeding within the last 6 months.
- The patient is participating in another research study involving another investigational device, procedure or drug.
- The brain AVM or DAVF or tumor has been previously treated with another embolization agent.
- The subject has a bleeding disorder.
- The subject is female and has a positive pregnancy test.
Show all 11Show fewer
- The subject has a life expectancy of less than 1 year.
- Subject has a known allergy to contrast media used for radiography.
- Subject has a known allergy to Dimethyl Sulfoxide - DMSO (solvent for the embolic product).
- Subject has a condition that would prevent them attending follow up visits for up to 1 year.
- -
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Prospective, Multicenter, Multinational Study to Assess the Safety and Performance of the Easyx Antia Liquid Embolic in Intracranial Interventions IDEALE Study
The study is a prospective, multicenter, multinational study to assess the safety and performance of the Easyx (trade name) Antia Liquid Embolic during embolization of intracranial malformations and fistulas. The clinical trial will include patients already scheduled for neuroradiological interventions. It is estimated that up to 8 sites will be required to collect the safety and performance data of the study material. Up to 65 patients will be enrolled in the study to achieve 53 evaluable patients. Each study centre will be required to treat 5 patients with a Dural arteriovenous fistula - DAVF before they can treat brain arteriovenous malformations - AVMs or brain tumours. Only experienced neuroradiologists will be invited to participate in this study.
Read the detailed description
Study Procedures Once the subject has agreed to participate in the study and has signed the consent form, the baseline visit can be performed. A full medical history will be taken and a physical exam will be done as per local routine practice for an embolization procedure. The Cognard scale will be performed to assess the grade of a DAVF and the Spetzler Martin grade will be assessed if a brain AVM is to be treated; these are standard scoring systems for brain DAVFs and AVMs. A neurological exam will be done and any abnormalities will be documented.
Procedure Embolization of the DAVF or BAVM or tumor will be done as per routine practice but using the Easyx product. The procedure to treat a BAVM or a tumor may be staged and complex DAVFs may require a second treatment to fully occlude the fistula. The plan for treatment will be noted at the procedure visit and subsequent planned interventions will not be classed as adverse events. All interventions up to the 12 month follow up visit will be recorded in the Case Report Forms - CRFs. If the preliminary angiogram immediately prior to treatment shows that the target area can no longer be treated with an embolic product, the patient will be withdrawn from the study at this point and alternative treatment as per routine practice will be planned. Procedure details will be noted and feedback from the treating interventionalist will be collected, to determine the ease of handling of the product.
If the DAVF occlusion is complete, an assessment of where occlusion has been performed will be noted. If the DAVF or BAVM occlusion or blockage of the supply to a tumor is incomplete, the reason for incomplete occlusion will be given. The subject will be asked to complete a visual analog scale immediately after the procedure to report on any pain. A neurological exam will be done post treatment to assess for any changes.
Discharge The subject's condition will be recorded at discharge. Adverse events will be reported as well as any subsequent imaging or interventions that occurred following the initial treatment. A neurological exam will be done and any changes will be recorded. The Rankin score will only be done if there has been a hemorrhagic or ischemic stroke; this is a well known stroke scale.
One Month Follow up A follow up visit will be done at the clinic one month after the initial treatment. Adverse events will be reported and any subsequent imaging or interventions that occurred following the initial treatment. A neurological exam will be done and any changes will be recorded. The Rankin score will only be done if there has been a hemorrhagic or ischemic stroke.
Three - Six Months Follow up A control cerebral imaging will be done as per local routine practice for an embolization procedure. This may include dynamic Magnetic Resonance MR-Angiography, CT or catheter angiography. Adverse events will also be reported. The Cognard score and the Martin Spetzler grade will be documented and a neurological exam will be done. The Rankin score will only be done if there has been a hemorrhagic or ischemic stroke.
Twelve Months Follow up A final follow up visit will be done at 12 months to determine if any adverse events have occurred. A neurological exam will be done and any changes will be recorded. The Rankin score will only be done if there has been a hemorrhagic or ischemic stroke. Subjects may be brought back as late as 14 months post procedure, to fit in with routine follow up.
Risks
The clinical risks associated with the use of of Easyx™ and the procedure to place the device are the same as any other marketed embolic product. These risks of the procedure include:
- Headache
- Too much blood sugar
- Infection
- Bleeding from access point for delivery catheter
- Bleeding in the brain or a blood clot in the brain leading to stroke
- Low or high blood pressure
- Inability to get to the area to be treated
- Difficulty to remove the delivery catheter, entrapment of the catheter, rupture of the catheter
- Rupture of a blood vessel due to mishandling of the catheter or due to an attempt to free a catheter that has become stuck to the embolic agent
- Abnormal heart rhythm
- A tear in the wall of the blood vessel
- Respiratory failure
- Seizures
- Spasm of the blood vessels
- Fainting
The specific risks associated with the delivery of the embolic product itself are:
- Inability to clearly see the embolized area
- Allergic reaction related to placement of the embolic product
- Spasm of the blood vessels due to the solvent in the embolic product
- Low platelet count
- Reflux or migration of the embolic product
- Bleeding events related to product delivery
- Pain after the procedure, related to product delivery
The risks associated with the delivery system include:
- Catheter entrapment
- Catheter clogging
- Catheter rupture
The risks associated with the delivery of the embolic product into the incorrect target area are:
- Damage to the function of the cranial nerve vessels
- Symptoms of stroke associated with product being in the wrong brain vessels
- Tissue damage in the surrounding area of the embolic product
- Incorrect placement in the venous system
Benefits The liquid embolic EasyxTM has proved to be feasible and safe for endovascular embolization in animal AVM and hypervascular animal models. The main advantages of the material are its even consistency, strongly bound iodine providing high visibility under x-ray, the non stick properties in relation to the delivery catheter and the adhesive properties in relation to easy placement of the product in the target vessel. Also, the product is ready to use and so does not need any preparation prior to placement in the target vessel. These advantages show that Easyx is easy to use in comparison to other products already on the market. EasyxTM has been shown to be biocompatible. The solvent is quickly dispersed in the surrounding tissue allowing the embolic product to quickly precipitate in situ and provide a solid cast in a target vessel lumen.
- Conditions
- Arterial Embolization
- Being tested
- Liquid Embolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liquid EmbolicDevice
Also called Easyx
The Easyx liquid embolic, manufactured by Antia AG, is intended to occlude hypervascular lesions in the brain such as tumors, arteriovenous malformations (a tangle of abnormal and poorly formed blood vessels) and dural arteriovenous fistulas (abnormal connection of blood vessels).
| Study group | Role | What they receive |
|---|---|---|
| Easyx Liquid Embolic | Experimental | embolization of intracranial malformations and fistulas and brain tumours with Easyx Liquid Embolic Receives: Device: Liquid Embolic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device related adverse events
The incidence of adverse events related to the device and procedure at 1 month follow up to ensure that the rate is equivalent to other products already on the market.
Measured: 1 month
Technical Success
The primary technical success endpoint is measured by evaluating the percentage achieved obliteration degree of the DAVF vascular lesion target or planned AVM region or vascular supply to a tumor. The assessment is done by means of a questionnaire
Measured: immediate
Secondary outcomes (3)
Status of the lesion
Comparison of Cognard score (I, IIa, IIb, III, IV, V) for DAVFs and Spetzler Martin Grade (0, I, II, III, IV, V) for BAVMs pre and post treatment and at 3-6 months.The measures will be recorded in tables identifying and separating the scores
Measured: 3 and 6 months
Useability
Analysis of usability by a procedure questionnaire on the handling of the Easyx product
Measured: immediate
Neurological changes
A qualitative assessment if neurological changes appears at 1 month, 6 months and 12 months. If yes the changes will be itemized and described individually in a table
Measured: 1, 6 and12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2016 (estimated)
- Study startOct 2016
- Primary completionOct 2017 (estimated)
- Study completionOct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arterial EmbolizationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Antia Therapeutics AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02863133
- Sponsor's protocol ID
- 028
- Acronym
- Ideale
- Status last verified
- Aug 2016
- First submitted
- 1 Aug 2016
- Last updated
- 11 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter, Multinational Study to Assess the Safety and Performance of the Easyx Antia Liquid Embolic in Intracranial Interventions IDEALE Study
- ClinicalTrials.gov ID
- NCT02863133
- Acronym / sponsor ID
- Ideale / 028
- Conditions
- Arterial Embolization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Antia Therapeutics AGIndustry (pharma, biotech, devices)
- Study start
- Oct 2016
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 11 Aug 2016 (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.
The study is a prospective, multicenter, multinational study to assess the safety and performance of the Easyx (trade name) Antia Liquid Embolic during embolization of intracranial malformations and fistulas. The clinical trial will include patients already scheduled for neuroradiological interventions. It is estimated that up to 8 sites will be required to collect the safety and performance data of the study material. Up to 65 patients will be enrolled in the study to achieve 53 evaluable patients. Each study centre will be required to treat 5 patients with a Dural arteriovenous fistula - DAVF before they can treat brain arteriovenous malformations - AVMs or brain tumours. Only experienced neuroradiologists will be invited to participate in this study.
Detailed description
Study Procedures Once the subject has agreed to participate in the study and has signed the consent form, the baseline visit can be performed. A full medical history will be taken and a physical exam will be done as per local routine practice for an embolization procedure. The Cognard scale will be performed to assess the grade of a DAVF and the Spetzler Martin grade will be assessed if a brain AVM is to be treated; these are standard scoring systems for brain DAVFs and AVMs. A neurological exam will be done and any abnormalities will be documented.
Procedure Embolization of the DAVF or BAVM or tumor will be done as per routine practice but using the Easyx product. The procedure to treat a BAVM or a tumor may be staged and complex DAVFs may require a second treatment to fully occlude the fistula. The plan for treatment will be noted at the procedure visit and subsequent planned interventions will not be classed as adverse events. All interventions up to the 12 month follow up visit will be recorded in the Case Report Forms - CRFs. If the preliminary angiogram immediately prior to treatment shows that the target area can no longer be treated with an embolic product, the patient will be withdrawn from the study at this point and alternative treatment as per routine practice will be planned. Procedure details will be noted and feedback from the treating interventionalist will be collected, to determine the ease of handling of the product.
If the DAVF occlusion is complete, an assessment of where occlusion has been performed will be noted. If the DAVF or BAVM occlusion or blockage of the supply to a tumor is incomplete, the reason for incomplete occlusion will be given. The subject will be asked to complete a visual analog scale immediately after the procedure to report on any pain. A neurological exam will be done post treatment to assess for any changes.
Discharge The subject's condition will be recorded at discharge. Adverse events will be reported as well as any subsequent imaging or interventions that occurred following the initial treatment. A neurological exam will be done and any changes will be recorded. The Rankin score will only be done if there has been a hemorrhagic or ischemic stroke; this is a well known stroke scale.
One Month Follow up A follow up visit will be done at the clinic one month after the initial treatment. Adverse events will be reported and any subsequent imaging or interventions that occurred following the initial treatment. A neurological exam will be done and any changes will be recorded. The Rankin score will only be done if there has been a hemorrhagic or ischemic stroke.
Three - Six Months Follow up A control cerebral imaging will be done as per local routine practice for an embolization procedure. This may include dynamic Magnetic Resonance MR-Angiography, CT or catheter angiography. Adverse events will also be reported. The Cognard score and the Martin Spetzler grade will be documented and a neurological exam will be done. The Rankin score will only be done if there has been a hemorrhagic or ischemic stroke.
Twelve Months Follow up A final follow up visit will be done at 12 months to determine if any adverse events have occurred. A neurological exam will be done and any changes will be recorded. The Rankin score will only be done if there has been a hemorrhagic or ischemic stroke. Subjects may be brought back as late as 14 months post procedure, to fit in with routine follow up.
Risks
The clinical risks associated with the use of of Easyx™ and the procedure to place the device are the same as any other marketed embolic product. These risks of the procedure include:
- Headache
- Too much blood sugar
- Infection
- Bleeding from access point for delivery catheter
- Bleeding in the brain or a blood clot in the brain leading to stroke
- Low or high blood pressure
- Inability to get to the area to be treated
- Difficulty to remove the delivery catheter, entrapment of the catheter, rupture of the catheter
- Rupture of a blood vessel due to mishandling of the catheter or due to an attempt to free a catheter that has become stuck to the embolic agent
- Abnormal heart rhythm
- A tear in the wall of the blood vessel
- Respiratory failure
- Seizures
- Spasm of the blood vessels
- Fainting
The specific risks associated with the delivery of the embolic product itself are:
- Inability to clearly see the embolized area
- Allergic reaction related to placement of the embolic product
- Spasm of the blood vessels due to the solvent in the embolic product
- Low platelet count
- Reflux or migration of the embolic product
- Bleeding events related to product delivery
- Pain after the procedure, related to product delivery
The risks associated with the delivery system include:
- Catheter entrapment
- Catheter clogging
- Catheter rupture
The risks associated with the delivery of the embolic product into the incorrect target area are:
- Damage to the function of the cranial nerve vessels
- Symptoms of stroke associated with product being in the wrong brain vessels
- Tissue damage in the surrounding area of the embolic product
- Incorrect placement in the venous system
Benefits The liquid embolic EasyxTM has proved to be feasible and safe for endovascular embolization in animal AVM and hypervascular animal models. The main advantages of the material are its even consistency, strongly bound iodine providing high visibility under x-ray, the non stick properties in relation to the delivery catheter and the adhesive properties in relation to easy placement of the product in the target vessel. Also, the product is ready to use and so does not need any preparation prior to placement in the target vessel. These advantages show that Easyx is easy to use in comparison to other products already on the market. EasyxTM has been shown to be biocompatible. The solvent is quickly dispersed in the surrounding tissue allowing the embolic product to quickly precipitate in situ and provide a solid cast in a target vessel lumen.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Easyx Liquid Embolic | Experimental | Device: Liquid Embolicembolization of intracranial malformations and fistulas and brain tumours with Easyx Liquid Embolic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject is aged 18 years or over
- Subject exhibits a DAVF or BAVM or tumor that has been selected for endovascular treatment
- Subject has provided written consent for the procedure.
- Subject agrees to all follow up visits required by the protocol
- The Subject is clinically and neurologically stable for a minimum of 48 hours prior to embolization.
Key exclusion criteria (11 listed)
- The subject has a brain AVM with high flow arteriovenous fistula that the investigator has determined to be unsuitable for embolization.
- The subject has had acute cerebral bleeding within the last 6 months.
- The patient is participating in another research study involving another investigational device, procedure or drug.
- The brain AVM or DAVF or tumor has been previously treated with another embolization agent.
- The subject has a bleeding disorder.
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 |
|---|---|---|
| Liquid EmbolicAlso: EasyxThe Easyx liquid embolic, manufactured by Antia AG, is intended to occlude hypervascular lesions in the brain such as tumors, arteriovenous malformations (a tangle of abnormal and poorly formed blood vessels) and dural arteriovenous fistulas (abnormal connection of blood vessels). | Device | Easyx Liquid Embolic |
Primary outcome
Device related adverse events
Time frame: 1 month
The incidence of adverse events related to the device and procedure at 1 month follow up to ensure that the rate is equivalent to other products already on the market.
Technical Success
Time frame: immediate
The primary technical success endpoint is measured by evaluating the percentage achieved obliteration degree of the DAVF vascular lesion target or planned AVM region or vascular supply to a tumor. The assessment is done by means of a questionnaire
3 secondary outcomes
Status of the lesion
Time frame: 3 and 6 months
Useability
Time frame: immediate
Neurological changes
Time frame: 1, 6 and12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2016.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Liquid Embolic in people with Arterial Embolization, run by Antia Therapeutics AG.
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 5 inclusion and 11 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 11 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Gert Andersen, B Sc (+4523600650, Gert.Andersen@antia.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device related adverse events (time frame: 1 month). 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 11 Aug 2016.