Brain Arteriovenous MalformationsPhase 2NCT00857662
Study Comparing Onyx and TRUFILL in Brain Arteriovenous Malformations (AVMs)
A Phase 2 study testing Onyx and TRUFILL in people with Brain Arteriovenous Malformations, run by Medtronic Neurovascular Clinical Affairs at 1 site in United States.
Trial summary
Test whether AVMs treated with Onyx is equivalent to treatment with n-BCA. Success is defined as an AVM size reduction greater than 50% Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Brain Arteriovenous Malformations
- What is being tested?
- Onyx and TRUFILL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteUnited States
- Study dates
- May 2001to Dec 2007
- Phase
- Phase 2
- 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
Who may be able to join
- The patient or patient's guardian understands and will sign the informed consent for the procedure
- The patient has a confirmed diagnosis of a brain AVM in the cerebral cortex, cerebellum or dura mater as visualized by angiography or cross sectional imaging.
- The brain AVM has a Spetzler-Martin grade of I, II, III, or IV. If the brain AVM has a Spetzler-Martin grade of I or II, the anticipated benefit of embolization for surgical resection is greater than the risk of the embolization procedure (e.g., patient stability).
- The patient is a candidate for surgical resection of the AVM post embolization.
- The patient is clinically and neurologically stable, for a minimum of 24 hours prior to embolization.
- The patient agrees to have, and is capable of completing, all study-related exams and procedures.
- Patient of any age.
Who cannot join
- The patient is pregnant.
- The patient has a brain AVM with high flow arteriovenous fistulae that the investigator has determined to be unsuitable for embolization.
- The brain AVM has a Spetzler-Martin grade of V.
- The patient is participating in another research study involving another investigational device, procedure or drug.
- The brain AVM has been previously treated with another embolization agent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: U.S. Multicenter, Randomized Controlled Study Comparing the Performance fo Onyx(EVOH) and TRUFILL® (n-BCA)in Presurgical Embolization of Brain Arteriovenous Malformations (BAVMs)
Test whether AVMs treated with Onyx is equivalent to treatment with n-BCA. Success is defined as an AVM size reduction greater than 50%
Read the detailed description
Recent advances in the endovascular treatment of arteriovenous malformations (AVMs) have increased the number of patients with brain AVMs for whom embolization therapy may be appropriate. The permanency of obliterated nidi and occurrence of procedural complications are thought to be at least partially influenced by the characteristics of the material used, with liquid agents more likely to reach and occlude the AVM nidus compared to particulate embolic agents.
The only liquid embolic agent approved in the U.S. for the presurgical embolization of AVMs is TRUFILL®. TRUFILL n-butyl cyanoacrylate (n-BCA) is a liquid adhesive that polymerizes into a solid material upon contact with blood fluids or tissue, via an anionic mechanism. TRUFILL Ethiodized Oil is mixed into the n-BCA monomer as a radiopaque polymerizing retardant. TRUFILL Tantalum Powder may also be added for radiopacity. The TRUFILL n-BCA Liquid Embolic System received U.S. FDA premarket approval on September 25, 2000 (P990040) for use in the embolization of cerebral AVMs, when presurgical devascularization is desired.
Onyx™ is a non-adhesive liquid embolic agent comprised of ethylene vinyl alcohol (EVOH) copolymer dissolved in dimethyl sulfoxide (DMSO), and of micronized tantalum powder. Onyx precipitates into a solid on contact with blood fluids, due to rapid diffusion of the DMSO solvent. The Onyx Liquid Embolic System received the European "CE mark" in July 1999, and has been available outside of the U.S. since September 1999 for use in the embolization of AVMs.
The purpose of this randomized-controlled study is to obtain prospective clinical data on the performance of Onyx (investigational device) and TRUFILL (control device) in the presurgical embolization of brain AVMs. Device safety will be assessed by comparing overall and device-related morbidity and mortality. The primary efficacy endpoint is the angiographic reduction in AVM size (volume) achieved. The objective is to demonstrate that Onyx is no worse than TRUFILL within a specified clinical tolerance. Study results will be used to support a premarket approval application for Onyx in the presurgical embolization of brain AVMs.
- Conditions
- Brain Arteriovenous Malformations
- Being tested
- Onyx, TRUFILL
- Keywords
- US Multicenter, Randomized, Onyx, Brain Arteriovenous Malformation (BAVMs)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OnyxDevice
Embolization
TRUFILLDevice
Embolization
| Study group | Role | What they receive |
|---|---|---|
| Onyx | Experimental | Not described Receives: Device: Onyx |
| TRUFILL | Active comparator | Not described Receives: Device: TRUFILL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Angiographic reduction in AVM size (volume) of 50% or greater, where angiographic size reduction is defined as the change from the original AVM size prior to any embolization procedure, to the AVM size after the last embolization.
Measured: Post final embolization
Secondary outcomes (3)
Safety will be assessed by the nature and severity of adverse events
Measured: 3 months post discharge
Surgical blood loss
Surgical resection time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2009 (estimated)
- Study startMay 2001
- Primary completionApr 2003
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Neurovascular Clinical Affairs
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Micro Therapeutics Inc.
- Investigators
- Gary Duckwiler, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00857662
- Sponsor's protocol ID
- G000296
- Status last verified
- Oct 2023
- First submitted
- 5 Mar 2009
- Last updated
- 27 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- U.S. Multicenter, Randomized Controlled Study Comparing the Performance fo Onyx(EVOH) and TRUFILL® (n-BCA)in Presurgical Embolization of Brain Arteriovenous Malformations (BAVMs)
- ClinicalTrials.gov ID
- NCT00857662
- Acronym / sponsor ID
- G000296
- Conditions
- Brain Arteriovenous Malformations
- Keywords
- US Multicenter, Randomized, Onyx, Brain Arteriovenous Malformation (BAVMs)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Medtronic Neurovascular Clinical AffairsIndustry (pharma, biotech, devices)
- Collaborators
- Micro Therapeutics Inc.
- Study start
- May 2001
- Primary completion
- Apr 2003 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 9 Mar 2009 (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.
Test whether AVMs treated with Onyx is equivalent to treatment with n-BCA. Success is defined as an AVM size reduction greater than 50%
Detailed description
Recent advances in the endovascular treatment of arteriovenous malformations (AVMs) have increased the number of patients with brain AVMs for whom embolization therapy may be appropriate. The permanency of obliterated nidi and occurrence of procedural complications are thought to be at least partially influenced by the characteristics of the material used, with liquid agents more likely to reach and occlude the AVM nidus compared to particulate embolic agents.
The only liquid embolic agent approved in the U.S. for the presurgical embolization of AVMs is TRUFILL®. TRUFILL n-butyl cyanoacrylate (n-BCA) is a liquid adhesive that polymerizes into a solid material upon contact with blood fluids or tissue, via an anionic mechanism. TRUFILL Ethiodized Oil is mixed into the n-BCA monomer as a radiopaque polymerizing retardant. TRUFILL Tantalum Powder may also be added for radiopacity. The TRUFILL n-BCA Liquid Embolic System received U.S. FDA premarket approval on September 25, 2000 (P990040) for use in the embolization of cerebral AVMs, when presurgical devascularization is desired.
Onyx™ is a non-adhesive liquid embolic agent comprised of ethylene vinyl alcohol (EVOH) copolymer dissolved in dimethyl sulfoxide (DMSO), and of micronized tantalum powder. Onyx precipitates into a solid on contact with blood fluids, due to rapid diffusion of the DMSO solvent. The Onyx Liquid Embolic System received the European "CE mark" in July 1999, and has been available outside of the U.S. since September 1999 for use in the embolization of AVMs.
The purpose of this randomized-controlled study is to obtain prospective clinical data on the performance of Onyx (investigational device) and TRUFILL (control device) in the presurgical embolization of brain AVMs. Device safety will be assessed by comparing overall and device-related morbidity and mortality. The primary efficacy endpoint is the angiographic reduction in AVM size (volume) achieved. The objective is to demonstrate that Onyx is no worse than TRUFILL within a specified clinical tolerance. Study results will be used to support a premarket approval application for Onyx in the presurgical embolization of brain AVMs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Onyx | Experimental | Device: Onyx |
| TRUFILL | Active comparator | Device: TRUFILL |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- The patient or patient's guardian understands and will sign the informed consent for the procedure
- The patient has a confirmed diagnosis of a brain AVM in the cerebral cortex, cerebellum or dura mater as visualized by angiography or cross sectional imaging.
- The brain AVM has a Spetzler-Martin grade of I, II, III, or IV. If the brain AVM has a Spetzler-Martin grade of I or II, the anticipated benefit of embolization for surgical resection is greater than the risk of the embolization procedure (e.g., patient stability).
- The patient is a candidate for surgical resection of the AVM post embolization.
- The patient is clinically and neurologically stable, for a minimum of 24 hours prior to embolization.
Key exclusion criteria (5 listed)
- The patient is pregnant.
- The patient has a brain AVM with high flow arteriovenous fistulae that the investigator has determined to be unsuitable for embolization.
- The brain AVM has a Spetzler-Martin grade of V.
- The patient is participating in another research study involving another investigational device, procedure or drug.
- The brain AVM has been previously treated with another embolization agent
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 |
|---|---|---|
| OnyxEmbolization | Device | Onyx |
| TRUFILLEmbolization | Device | TRUFILL |
Primary outcome
Angiographic reduction in AVM size (volume) of 50% or greater, where angiographic size reduction is defined as the change from the original AVM size prior to any embolization procedure, to the AVM size after the last embolization.
Time frame: Post final embolization
3 secondary outcomes
Safety will be assessed by the nature and severity of adverse events
Time frame: 3 months post discharge
Surgical blood loss
Surgical resection time
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 27 Oct 2023.
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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.
Gary Duckwiler, MD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Onyx and TRUFILL in people with Brain Arteriovenous Malformations, run by Medtronic Neurovascular Clinical Affairs at 1 site in United States.
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 7 inclusion and 5 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 27 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Angiographic reduction in AVM size (volume) of 50% or greater, where angiographic size reduction is defined as the change from the original AVM size prior to any embolization procedure, to the AVM size after the last embolization. (time frame: Post final embolization). 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 27 Oct 2023.