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The purpose of this study is to evaluate the safety of the Apolloâ„¢ Onyxâ„¢ Delivery Microcatheter used for delivery of the Onyxâ„¢ Liquid Embolic System during brain arteriovenous malformation (AVM) embolization procedures.
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 Apolloâ„¢ Onyxâ„¢ Delivery Microcatheter versus any a standard catheter represents leaving behind a 1.5 - 3.0 cm long detachable tip in the Onyxâ„¢ Onyxâ„¢ Delivery Microcatheter cast versus an average 165 cm long catheter in the vasculature.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AVM treatment | Other | Apolloâ„¢ Onyxâ„¢ Delivery Micro Catheter |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apolloâ„¢ Onyxâ„¢ Delivery Micro Catheter | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 30 days, after treatment with Onyxâ„¢ embolization using Apolloâ„¢ Onyxâ„¢ Delivery Microcatheter |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Premature (Unintentional) Catheter Tip Detachment at 30 Days | Rate of premature (unintentional) catheter tip detachment | 30 days |
| Number of Participants With Intentional Catheter Tip Detachment at 30 Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohammed A Aziz-Sultan, MD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radiology Imaging Associates, P.C. | Englewood | Colorado | 80112 | United States | ||
| Brigham's & Women Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33526480 | Derived | 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. |
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Generally we do not plan to share the IPD. Researchers can contact the Sponsor if interested.
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| ID | Title | Description |
|---|---|---|
| FG000 | APOLLO | The Apolloâ„¢ Onyxâ„¢ Delivery Microcatheter used for delivery of the Onyxâ„¢ Liquid Embolic System during brain AVM embolization procedures. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Enrollment |
|
| |||||||||||||||||||||
| Discharge |
| ||||||||||||||||||||||
| 30 Day Follow-Up |
| ||||||||||||||||||||||
| 12 Months Follow-Up |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | APOLLO | The Apolloâ„¢ Onyxâ„¢ Delivery Microcatheter used for delivery of the Onyxâ„¢ Liquid Embolic System during brain AVM embolization procedures. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | The Apolloâ„¢ Onyxâ„¢ Delivery Microcatheter used for delivery of the Onyxâ„¢ Liquid Embolic System during brain AVM embolization procedures. | Posted | Count of Participants | Participants | 30 days, after treatment with Onyxâ„¢ embolization using Apolloâ„¢ Onyxâ„¢ Delivery Microcatheter |
|
|
Adverse events were collected from the point of enrollment in the study until a subject exited the study (at 30-days or 12-months)
The adverse event data was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria:
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | APOLLO | The Apolloâ„¢ Onyxâ„¢ Delivery Microcatheter used for delivery of the Onyxâ„¢ Liquid Embolic System during brain AVM embolization procedures. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Haemorrhagic anaemia | Blood and lymphatic system disorders | MedDRA (20.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bradycardia | Cardiac disorders | MedDRA (20.0) | Systematic Assessment |
Study was completed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Darren Lacour, Sr. Manager, Clinical Project Management | Medtronic Neurovascular | 949-680-1274 | darren.j.lacour@medtronic.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 5, 2014 | Feb 26, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001165 | Arteriovenous Malformations |
| D001927 | Brain Diseases |
| ID | Term |
|---|---|
| D054079 | Vascular Malformations |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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Rate of intentional catheter tip detachment
| 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 | 30 days |
| Number of Participants With Catheter/Tip Leakage From Detachment Zone at 30 Days | Rate of catheter/tip leakage from detachment zone | 30 days |
| Number of Participants With Catheter-related Adverse Events at 30 Days | Incidence of catheter-related adverse events at 30 days | 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) | 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) | 12 months |
| Boston |
| Massachusetts |
| 02115 |
| United States |
|
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Smoking | Count of Participants | Participants |
|
| Participants |
|
|
| Secondary | Number of Participants With Premature (Unintentional) Catheter Tip Detachment at 30 Days | Rate of premature (unintentional) catheter tip detachment | Participants treated with Onyxâ„¢ embolization using Apolloâ„¢ Onyxâ„¢ Delivery Microcatheter | Posted | Count of Participants | Participants | 30 days |
|
|
|
| Secondary | Number of Participants With Intentional Catheter Tip Detachment at 30 Days | Rate of intentional catheter tip detachment | Participants treated with Onyxâ„¢ embolization using Apolloâ„¢ Onyxâ„¢ Delivery Microcatheter | Posted | Count of Participants | Participants | 30 days |
|
|
|
| Secondary | Number of Participants With Migration of Retained Catheter Tip Post Embolization at 30 Days | Rate of migration of the retained catheter tip post embolization | Participants treated with Onyxâ„¢ embolization using Apolloâ„¢ Onyxâ„¢ Delivery Microcatheter | Posted | Count of Participants | Participants | 30 days |
|
|
|
| Secondary | Number of Participants With Catheter/Tip Leakage From Detachment Zone at 30 Days | Rate of catheter/tip leakage from detachment zone | Participants treated with Onyxâ„¢ embolization using Apolloâ„¢ Onyxâ„¢ Delivery Microcatheter | Posted | Count of Participants | Participants | 30 days |
|
|
|
| Secondary | Number of Participants With Catheter-related Adverse Events at 30 Days | Incidence of catheter-related adverse events at 30 days | Participants treated with Onyxâ„¢ embolization using Apolloâ„¢ Onyxâ„¢ Delivery Microcatheter | Posted | Count of Participants | Participants | 30 days |
|
|
|
| Secondary | 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) | Participants treated with Onyxâ„¢ embolization using Apolloâ„¢ Onyxâ„¢ Delivery Microcatheter | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Secondary | 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) | Participants treated with Onyxâ„¢ embolization using Apolloâ„¢ Onyxâ„¢ Delivery Microcatheter | Posted | Count of Participants | Participants | 12 months |
|
|
|
| 3 |
| 112 |
| 39 |
| 112 |
| 51 |
| 112 |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (20.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Brain abscess | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
|
| Postoperative wound infection | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
|
| Urosepsis | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
|
| Procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
|
| Subarachnoid haemorrhage | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
|
| Subdural haemorrhage | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
|
| Vascular injury | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
|
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
|
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA (20.0) | Systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | Systematic Assessment |
|
| Aphasia | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
|
| Brain oedema | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
|
| Cerebrospinal fluid leakage | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
|
| Encephalopathy | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
|
| Haemorrhage intracranial | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
|
| Haemorrhagic stroke | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
|
| Hemianopia | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
|
| Hemiparesis | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
|
| Hydrocephalus | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
|
| Intracranial pressure increased | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
|
| Intraventricular haemorrhage | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
|
| Ischaemic stroke | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
|
| Monoparesis | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
|
| Seizure | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
|
| Alcohol withdrawal syndrome | Psychiatric disorders | MedDRA (20.0) | Systematic Assessment |
|
| Hallucination | Psychiatric disorders | MedDRA (20.0) | Systematic Assessment |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Respiratory tract oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Air embolism | Vascular disorders | MedDRA (20.0) | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA (20.0) | Systematic Assessment |
|
| Vessel perforation | Vascular disorders | MedDRA (20.0) | Systematic Assessment |
|
| Diplopia | Eye disorders | MedDRA (20.0) | Systematic Assessment |
|
| Photophobia | Eye disorders | MedDRA (20.0) | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA (20.0) | Systematic Assessment |
|
| Visual impairment | Eye disorders | MedDRA (20.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Adverse drug reaction | General disorders | MedDRA (20.0) | Systematic Assessment |
|
| Chest Pain | General disorders | MedDRA (20.0) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (20.0) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
|
| Pneumocephalus | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
|
| Pseudomeningocele | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
|
| Subarachnoid haemorrhage | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
|
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
|
| Vascular access site haematoma | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
|
| Vascular access site haemorrhage | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (20.0) | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (20.0) | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (20.0) | Systematic Assessment |
|
| Brain oedema | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
|
| Cerebral artery thrombosis | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
|
| Cerebral vasoconstriction | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
|
| Dysmetria | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
|
| Facial paralysis | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
|
| Haemorrhage intracranial | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
|
| Hemianopia homonymous | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
|
| Ischaemic stroke | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
|
| Quadrantanopia | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
|
| Seizure | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
|
| Vertebral artery dissection | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA (20.0) | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA (20.0) | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (20.0) | Systematic Assessment |
|
| Thrombophlebitis superficial | Vascular disorders | MedDRA (20.0) | Systematic Assessment |
|
| Vasospasm | Vascular disorders | MedDRA (20.0) | Systematic Assessment |
|
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| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |