Ignite Creation Date:
2024-05-06 @ 2:31 AM
Last Modification Date:
2024-10-26 @ 11:19 AM
Study NCT ID:
NCT02060682
Status:
COMPLETED
Last Update Posted:
2019-12-09
First Post:
2014-02-07
Brief Title:
Post-Market Registry of the ACIST CPM System and Navvus Catheter in Clinical Practice
Sponsor:
Acist Medical Systems
Organization:
Acist Medical Systems
Study Overview
Official Title:
Post-Market Registry of the ACIST Cardiovascular Pressure Measurement CPM System and Navvus Catheter in Clinical Practice-ADVANCE-EU
Status:
COMPLETED
Status Verified Date:
2019-12
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:
ADVANCE-EU
Brief Summary:
This registry will collect real-world clinical evidence on the performance safety and usability of the ACIST CPM System and NAVVUS Catheter when used in accordance with approved labeling in a European commercial setting Up to 60 subjects will have Fractional Flow Reserve FFR measurements of coronary lesions attempted with the CPM System and NAVVUS Catheter All subjects will receive diagnostic treatment according to clinical indications and center standard practice
Detailed Description:
There are no protocol-specific procedural requirements for this registry Enrolled subjects will undergo a diagnostic angiography procedure including an FFR measurement with the CPM System and NAVVUS Catheter according to the center standard of care and the Instructions for Use of the CPM System and Navvus Catheter Participants will be followed for the duration of hospital stay an expected average of 1 day
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