Trials / Completed
CompletedNCT02085278
Safety of Apollo Micro Catheter in Pediatric Patients
Safety of Apollo Embolization Delivery Micro Catheter in Pediatric Patients With Vascular Malformations
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 10 (actual)
- Sponsor
- St. Luke's-Roosevelt Hospital Center · Academic / Other
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
Summary
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).
Detailed description
-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 Onyx™ 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Apollo Micro Catheter device | Detachable Tip Micro catheter |
Timeline
- Start date
- 2014-02-01
- Primary completion
- 2015-06-01
- Completion
- 2015-06-01
- First posted
- 2014-03-12
- Last updated
- 2019-01-25
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02085278. Inclusion in this directory is not an endorsement.