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Post-Market Registry of the ACIST CPM System and Navvus Catheter in Clinical Practice — ADVANCE-EU  

Coronary Artery Disease Clinical Trial

Official title:
Post-Market Registry of the ACIST Cardiovascular Pressure Measurement (CPM) System and Navvus Catheter in Clinical Practice-ADVANCE-EU

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02060682
Study type Observational [Patient Registry]
Source Acist Medical Systems
Contact
Status Completed
Phase
Start date February 2014
Completion date July 2014
View Details
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