Apollo™ Onyx™ Delivery Micro Catheter Post Market Safety Study
| Status: | Completed |
|---|---|
| Conditions: | Cardiology, Women's Studies, Hematology |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Hematology, Reproductive |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 9/21/2018 |
| Start Date: | May 18, 2015 |
| End Date: | February 20, 2018 |
The purpose of this study is to evaluate the safety of the Apollo™ Onyx™ Delivery Micro
Catheter used for delivery of the Onyx™ Liquid Embolic System during brain arteriovenous
malformation (AVM) embolization procedures.
Catheter used for delivery of the Onyx™ Liquid Embolic System during brain arteriovenous
malformation (AVM) embolization procedures.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
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