Ignite Creation Date:
2024-05-06 @ 2:00 AM
Last Modification Date:
2024-10-26 @ 11:12 AM
Study NCT ID:
NCT01949779
Status:
COMPLETED
Last Update Posted:
2019-09-06
First Post:
2013-09-20
Brief Title:
TransForm Occlusion Balloon Catheter Registry
Sponsor:
Stryker Neurovascular
Organization:
Stryker Neurovascular
Study Overview
Official Title:
TransForm Occlusion Balloon Catheter Registry
Status:
COMPLETED
Status Verified Date:
2019-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None