Ignite Creation Date:
2024-05-05 @ 9:26 PM
Last Modification Date:
2024-10-26 @ 10:04 AM
Study NCT ID:
NCT00886899
Status:
COMPLETED
Last Update Posted:
2012-03-20
First Post:
2009-04-21
Brief Title:
Facilitated Antegrade Steering Technique in Chronic Total Occlusions FAST-CTOs
Sponsor:
BridgePoint Medical
Organization:
BridgePoint Medical
Study Overview
Official Title:
Facilitated Antegrade Steering Technique in Chronic Total Occlusions
Status:
COMPLETED
Status Verified Date:
2012-03
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:
FAST-CTOs
Brief Summary:
Prospective non-randomized multicenter study in subjects with coronary artery chronic total occlusions CTOs Published results of safety and effectiveness of conventional techniques will be used for comparison Enrollment of up to 149 subjects with a CTO refractory to currently marketed guidewire use and meeting all inclusionexclusion criteria at up to 15 US clinical sites Hypothesis is that the BridgePoint Medical System is safe and effective in treating coronary CTOs compared to CTO literature
Detailed Description:
None
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