Arteriovenous MalformationsNCT02378883
Apollo™ Onyx™ Delivery Microcatheter Post Market Safety Study
A study testing Apollo™ Onyx™ Delivery Micro Catheter in people with Arteriovenous Malformations, run by Medtronic Neurovascular Clinical Affairs at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety of the Apollo™ Onyx™ Delivery Microcatheter used for delivery of the Onyx™ Liquid Embolic System during brain arteriovenous malformation (AVM) embolization procedures. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Arteriovenous Malformations
- What is being tested?
- Apollo™ Onyx™ Delivery Micro Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 May 2015to 20 Feb 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Subject or Subject's legally authorized representative has signed and dated an informed consent form.
- The Subject has a confirmed diagnosis of a brain AVM.
- The Subject is clinically and neurologically stable for a minimum of 48 hours prior to embolization.
- The Subject has a life expectancy of at least 1 year.
- The Subject agrees to and is capable of completing all study-required procedures.
Who cannot join
- Current participation in another investigational drug or device study that evaluates treatments for brain AVMs or other cerebrovascular disease.
- The Subject has a bleeding disorder.
- The Subject is not a candidate for the use of vasodilators.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Brigham's & Women Hospital
Boston, Massachusetts, 02115
Radiology Imaging Associates, P.C.
Englewood, Colorado, 80112
About this study
The purpose of this study is to evaluate the safety of the Apollo™ Onyx™ Delivery Microcatheter used for delivery of the Onyx™ Liquid Embolic System during brain arteriovenous malformation (AVM) embolization procedures.
Read the detailed description
This study is a prospective, single-arm, multicenter, post-market safety evaluation of subjects indicated for embolization of brain AVMs with the study device. The study device was developed to potentially minimize the side effects of catheter retainment and increased procedural risk associated with alternative methods necessary for removing entrapped catheters. In the event of catheter retainment, using the Apollo™ Onyx™ Delivery Microcatheter versus any a standard catheter represents leaving behind a 1.5 - 3.0 cm long detachable tip in the Onyx™ Onyx™ Delivery Microcatheter cast versus an average 165 cm long catheter in the vasculature.
- Conditions
- Arteriovenous Malformations
- Being tested
- Apollo™ Onyx™ Delivery Micro Catheter
- Keywords
- Apollo, Onyx, Arteriovenous malformation, AVM, Onyx™ Liquid Embolic System, Apollo™ Onyx™ Delivery Microcatheter, Brain Diseases
- Medical subject headings
- Arteriovenous Malformations, Brain Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apollo™ Onyx™ Delivery Micro CatheterDevice
| Study group | Role | What they receive |
|---|---|---|
| AVM treatment | Other | Apollo™ Onyx™ Delivery Micro Catheter Receives: Device: Apollo™ Onyx™ Delivery Micro Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Catheter-related Adverse Events at 30 Days
Premature (unintentional) catheter tip detachment with clinical sequelae
Catheter rupture/break/fracture with clinical sequelae
Retained catheter body in the vasculature
Measured: 30 days, after treatment with Onyx™ embolization using Apollo™ Onyx™ Delivery Microcatheter
Secondary outcomes (7)
Number of Participants With Premature (Unintentional) Catheter Tip Detachment at 30 Days
Rate of premature (unintentional) catheter tip detachment
Measured: 30 days
Number of Participants With Intentional Catheter Tip Detachment at 30 Days
Rate of intentional catheter tip detachment
Measured: 30 days
Number of Participants With Migration of Retained Catheter Tip Post Embolization at 30 Days
Rate of migration of the retained catheter tip post embolization
Measured: 30 days
Number of Participants With Catheter/Tip Leakage From Detachment Zone at 30 Days
Rate of catheter/tip leakage from detachment zone
Measured: 30 days
Number of Participants With Catheter-related Adverse Events at 30 Days
Incidence of catheter-related adverse events at 30 days
Measured: 30 days
Number of Participants With Catheter-related Adverse Events at 12 Months
Number of participants with catheter-related adverse events at 12 months (long term secondary endpoint)
Measured: 12 months
Number of Participants With Migration of Retained Catheter Tip Post Embolization at 12 Months
Rate of migration of the retained catheter tip post embolization (long-term secondary endpoint)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2015 (estimated)
- Study start18 May 2015
- Primary completion20 Feb 2018
- Study completion20 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Neurovascular Clinical Affairs
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mohammed A Aziz-Sultan, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02378883
- Sponsor's protocol ID
- NV-APL001
- Status last verified
- Mar 2019
- First submitted
- 24 Feb 2015
- Last updated
- 29 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: Generally we do not plan to share the IPD. Researchers can contact the Sponsor if interested.
Publications
Meyers PM, Fifi JT, Cockroft KM, Miller TR, Given CA, Zomorodi AR, Jagadeesan BD, Mokin M, Kan P, Yao TL, Diaz O, Huddle D, Bellon RJ, Seinfeld J, Polifka AJ, Fiorella D, Chitale RV, Kvamme P, Morrow JT, Singer J, Wakhloo AK, Puri AS, Deshmukh VR, Hanel RA, Gonzalez LF, Woo HH, Aziz-Sultan MA. Safety of the APOLLO Onyx delivery microcatheter for embolization of brain arteriovenous malformations: results from a prospective post-market study. J Neurointerv Surg. 2021 Oct;13(10):935-941. doi: 10.1136/neurintsurg-2020-016830. Epub 2021 Feb 1.
PubMed 33526480
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Apollo™ Onyx™ Delivery Microcatheter Post Market Safety Study
- ClinicalTrials.gov ID
- NCT02378883
- Acronym / sponsor ID
- NV-APL001
- Conditions
- Arteriovenous Malformations
- Keywords
- Apollo, Onyx, Arteriovenous malformation, AVM, Onyx™ Liquid Embolic System, Apollo™ Onyx™ Delivery Microcatheter, Brain Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Medtronic Neurovascular Clinical AffairsIndustry (pharma, biotech, devices)
- Study start
- 18 May 2015 (actual)
- Primary completion
- 20 Feb 2018 (actual)
- Study completion
- 20 Feb 2018 (actual)
- First posted
- 4 Mar 2015 (estimated)
- Results
- Posted 29 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety of the Apollo™ Onyx™ Delivery Microcatheter used for delivery of the Onyx™ Liquid Embolic System during brain arteriovenous malformation (AVM) embolization procedures.
Detailed description
This study is a prospective, single-arm, multicenter, post-market safety evaluation of subjects indicated for embolization of brain AVMs with the study device. The study device was developed to potentially minimize the side effects of catheter retainment and increased procedural risk associated with alternative methods necessary for removing entrapped catheters. In the event of catheter retainment, using the Apollo™ Onyx™ Delivery Microcatheter versus any a standard catheter represents leaving behind a 1.5 - 3.0 cm long detachable tip in the Onyx™ Onyx™ Delivery Microcatheter cast versus an average 165 cm long catheter in the vasculature.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AVM treatment | Other | Device: Apollo™ Onyx™ Delivery Micro CatheterApollo™ Onyx™ Delivery Micro Catheter |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- The Subject or Subject's legally authorized representative has signed and dated an informed consent form.
- The Subject has a confirmed diagnosis of a brain AVM.
- The Subject is clinically and neurologically stable for a minimum of 48 hours prior to embolization.
- The Subject has a life expectancy of at least 1 year.
- The Subject agrees to and is capable of completing all study-required procedures.
Key exclusion criteria (3 listed)
- Current participation in another investigational drug or device study that evaluates treatments for brain AVMs or other cerebrovascular disease.
- The Subject has a bleeding disorder.
- The Subject is not a candidate for the use of vasodilators.
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 |
|---|---|---|
| Apollo™ Onyx™ Delivery Micro Catheter | Device | AVM treatment |
Primary outcome
Number of Participants With Catheter-related Adverse Events at 30 Days
Time frame: 30 days, after treatment with Onyx™ embolization using Apollo™ Onyx™ Delivery Microcatheter
Premature (unintentional) catheter tip detachment with clinical sequelae Catheter rupture/break/fracture with clinical sequelae Retained catheter body in the vasculature
7 secondary outcomes
Number of Participants With Premature (Unintentional) Catheter Tip Detachment at 30 Days
Time frame: 30 days
Number of Participants With Intentional Catheter Tip Detachment at 30 Days
Time frame: 30 days
Number of Participants With Migration of Retained Catheter Tip Post Embolization at 30 Days
Time frame: 30 days
Number of Participants With Catheter/Tip Leakage From Detachment Zone at 30 Days
Time frame: 30 days
Number of Participants With Catheter-related Adverse Events at 30 Days
Time frame: 30 days
Number of Participants With Catheter-related Adverse Events at 12 Months
Time frame: 12 months
Number of Participants With Migration of Retained Catheter Tip Post Embolization at 12 Months
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33526480Meyers PM, Fifi JT, Cockroft KM, Miller TR, Given CA, Zomorodi AR, Jagadeesan BD, Mokin M, Kan P, Yao TL, Diaz O, Huddle D, Bellon RJ, Seinfeld J, Polifka AJ, Fiorella D, Chitale RV, Kvamme P, Morrow JT, Singer J, Wakhloo AK, Puri AS, Deshmukh VR, Hanel RA, Gonzalez LF, Woo HH, Aziz-Sultan MA. Safety of the APOLLO Onyx delivery microcatheter for embolization of brain arteriovenous malformations: results from a prospective post-market study. J Neurointerv Surg. 2021 Oct;13(10):935-941. doi: 10.1136/neurintsurg-2020-016830. Epub 2021 Feb 1.
- Individual participant dataSharing planned: No. Generally we do not plan to share the IPD. Researchers can contact the Sponsor if interested.
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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.
Mohammed A Aziz-Sultan, MD principal investigator
Brigham and Women's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Apollo™ Onyx™ Delivery Micro Catheter in people with Arteriovenous Malformations, run by Medtronic Neurovascular Clinical Affairs at 2 sites 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 5 inclusion and 3 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 29 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Catheter-related Adverse Events at 30 Days (time frame: 30 days, after treatment with Onyx™ embolization using Apollo™ Onyx™ Delivery Microcatheter). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02378883, which also lists 1 linked publication.
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 29 Apr 2019.