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This is a clinical trial/study for patients diagnosed with brain arteriovenous malformation (AVM). An AVM is an abnormal connection between the arteries and veins of the brain. Patients considered for this trial are 21 years and younger with AVM suitable for embolization treatment (a procedure used to block the abnormal connection between the arteries and veins of the brain) with Onyx Liquid Embolic System (Onyx LES) or TruFill n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System (both are liquid substances used in the embolization procedure to block the abnormal connection).
-Why is this study being done?
The purpose of this study is to evaluate the safety of the Apollo Embolization Delivery Micro Catheter device (device that looks like a long thin hallow tube) when used in Pediatric patients with vascular malformations.
The Apollo Onyx Delivery Micro Catheter device is manufactured by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. Apollo Onyxâ„¢ Delivery Micro Catheter device is not approved for use in the U.S, although it is widely used and approved for use in Europe (CE0297).
This clinical study is sponsored by Dr. Alejandro Berenstein of St.Luke's-Roosevelt Hospital, New York who is also the principal Investigator of the study. Total duration of study is up to 30 months with approximately an 18 months enrollment period. Patients follow up period is up to 12 months upon enrollment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Apollo Group | Experimental | Apollo Micro catheter device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apollo Micro Catheter device | Device | Detachable Tip Micro catheter |
|
| Measure | Description | Time Frame |
|---|---|---|
| The study's primary endpoint is the incidence of catheter entrapment. | The study's primary endpoint is the incidence of catheter entrapment. Catheter entrapment entails any part of the Apollo Micro catheter Delivery Device, excluding the catheter tip, being inadvertently left within the vasculature at the end of the procedure | Within 24 hours after embolization |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of unintentional catheter tip detachment. | Defined by the separation of the detachment joint during the procedure either during navigation, prior to embolization completion, or upon catheter retrieval when distal tip is not entrapped in Onyx cast. | Within 24 hours after embolization |
| Incidence of migration of the detached catheter tip. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ahmed Otokiti, MBBS | St. Luke's-Roosevelt Hospital Center | Study Director |
| Alejandro Berenstein, M.D | St. Luke's-Roosevelt Hospital Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St.Luke's-Roosevelt Hospital | New York | New York | 10019 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12823868 | Background | Chang SD, Marcellus ML, Marks MP, Levy RP, Do HM, Steinberg GK. Multimodality treatment of giant intracranial arteriovenous malformations. Neurosurgery. 2003 Jul;53(1):1-11; discussion 11-3. doi: 10.1227/01.neu.0000068700.68238.84. | |
| 21990795 | Background | Walcott BP, Gerrard JL, Nogueira RG, Nahed BV, Terry AR, Ogilvy CS. Microsurgical retrieval of an endovascular microcatheter trapped during Onyx embolization of a cerebral arteriovenous malformation. J Neurointerv Surg. 2011 Mar;3(1):77-9. doi: 10.1136/jnis.2010.002733. Epub 2010 Oct 5. |
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| ID | Term |
|---|---|
| D020785 | Central Nervous System Vascular Malformations |
| D054080 | Vein of Galen Malformations |
| D001165 | Arteriovenous Malformations |
| ID | Term |
|---|---|
| D009421 | Nervous System Malformations |
| D009422 | Nervous System Diseases |
| D054079 | Vascular Malformations |
| D018376 | Cardiovascular Abnormalities |
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Defined by an observed change in position of the detached tip during post embolization imaging. |
| Within 24 hours after embolization |
| Incidence of catheter/procedure-related adverse events. | The adverse events include but not limited to vascular occlusion (a sudden blockage of a blood vessel usually with a blood clot), vascular thrombosis (acute and subacute) (blood clots in a vessel that break loose and enter another vessel), allergic reactions, thrombocytopenia (significant decrease in red blood cell clotting factors), Death, neurologic deterioration (nervous system decline) including stroke and death, pulmonary embolization or complications (blockage of blood vessels in the lung), perforation or dissection of the vessel (tear of the blood vessel). | At one year post procedure |
| Incidence of catheter/tip leakage from the detachment zone. | At one year post procedure |
| Incidence of migration of the detached catheter tip | Defined by an observed change in position of the detached tip during the post embolization imaging. | At one year post procedure |
| 20465885 | Background | Santillan A, Zink W, Knopman J, Riina H, Gobin YP. Balloon-assisted technique for trapped microcatheter retrieval following onyx embolization. A case report. Interv Neuroradiol. 2009 Dec;15(4):453-5. doi: 10.1177/159101990901500414. Epub 2009 Dec 28. |
| 21990504 | Background | Newman CB, Park MS, Kerber CW, Levy ML, Barr JD, Pakbaz RS. Over-the-catheter retrieval of a retained microcatheter following Onyx embolization: a technical report. J Neurointerv Surg. 2012 Jul;4(4):e13. doi: 10.1136/neurintsurg-2011-010040. Epub 2011 Jun 16. |
| D002318 | Cardiovascular Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D002538 | Intracranial Arteriovenous Malformations |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D014652 | Vascular Diseases |
| D020765 | Intracranial Arterial Diseases |