Intracranial Aneurysms Clinical Trial
Official title:
TransForm™ Occlusion Balloon Catheter Registry
The primary objective of this registry is to collect real world data on the safety and performance of the TransForm™ Occlusion Balloon Catheter when used in current neurointerventional procedures
- This is a prospective, single-arm, non-randomized, multi-center, observational registry.
- The expected duration for study enrollment is approximately 6 months-1 year.
- Study participation for each subject will be completed upon removal of the guide
catheter post-procedure.
- Up to 140 subjects will be enrolled at up to 15 study sites. A given site will be
allowed to enroll a maximum of 20 subjects.
- Enrollment in the registry occurs after a signed Informed Consent Form has been
obtained, and the index procedure starts.
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