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

Completed

• Conditions: Coronary Artery Disease
• Interventions: Device: Navvus Catheter FFR

• Registration Number: NCT02060682
• Lead Sponsor: Acist Medical Systems

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 Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-02-07
• Study First Submitted QC: 2014-02-11
• Study First Posted: 2014-02-12
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-06
• Last Update Posted: 2019-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Subjects 18 years of age or older in whom FFR measurement is indicated to guide percutaneous coronary intervention (PCI) strategy and use of the ACIST CPM System and Navvus Catheter is attempted.

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Navvus Catheter FFR	Navvus Catheter FFR	The Navvus Catheter is a rapid exchange microcatheter with a pressure sensor at the distal tip that measures Fractional Flow Reserve measurements to guide PCI treatment strategy.

Primary Outcome Measures

Name	Time	Method
Procedural Success	From enrollment through hospital discharge, an expected average of 1 day.	Procedural success is defined as the ability of the ACIST CPM System and NAVVUS Catheter to acquire FFR measurement without adverse device effect or device malfunction.

Trial Locations

Locations (7)

Hospital Privé Jacques Cartier; 🇫🇷 Massy, France

Centre Cardiologique du Nord; 🇫🇷 St. Denis, France

Johann Wolfgang Goethe Universität; 🇩🇪 Frankfurt, Germany

Klinikum Fulda gAG; 🇩🇪 Fulda, Germany

Universitätsmedizin der Johannes Gutenberg-Universität Mainz; 🇩🇪 Mainz, Germany

Ospedale San Raffaele; 🇮🇹 Milan, Italy

Hospital Universitario San Juan de Alicante; 🇪🇸 Alicante, Spain