Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06446024
Status:
RECRUITING
Last Update Posted:
2024-06-06
First Post:
2024-05-13
Brief Title:
Post Market Surveillance to Evaluate the Efficacy and Safety of the INDIGO Aspiration System in Japan
Sponsor:
Penumbra Inc
Organization:
Penumbra Inc
Study Overview
Official Title:
Post Market Surveillance to Evaluate the Efficacy and Safety of the INDIGO Aspiration System in Japan
Status:
RECRUITING
Status Verified Date:
2024-07
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:
JapanIndigoPMS
Brief Summary:
This study aims to confirm the safety and effectiveness of the INDIGO Aspiration System in patients requiring immediate treatment for acute lower extremity artery occlusion acute superior mesenteric artery occlusion or severe acute deep vein thrombosis Primary objective of the study is to collect predetermined data on use safety and effectiveness including clinical and technical performance of the INDIGO System in Japan
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None