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Clinical Trial Summary

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


Clinical Trial Description

- 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01949779
Study type Observational [Patient Registry]
Source Stryker Neurovascular
Contact
Status Completed
Phase
Start date December 2013
Completion date January 2015

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