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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02060682

Acronym

ADVANCE-EU

Enrollment

Registered

2014-02-12

Start date

2014-02-28

Completion date

2014-07-31

Last updated

2019-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

Fractional Flow Reserve, Rapid Exchange, Catheter

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.

Interventions

DEVICENavvus 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).

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

France, Germany, Italy, Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026