NCT02060682

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 60 (actual)
• Sponsor: Acist Medical Systems · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	Navvus Catheter FFR	Navvus Catheter provides Fractional Flow Reserve (FFR) measurement for each lesion identified according to standard of care of the center and the Instructions for Use (IFU).

Timeline

• Start date: 2014-02-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2014-02-12
• Last updated: 2019-12-09

Locations

7 sites across 4 countries: France, Germany, Italy, Spain