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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Privé Jacques Cartier, Massy, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Navvus Catheter FFR

Device

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).

Primary outcomes

Procedural Success

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Acist Medical Systems

Industry

Registry information

Official study title

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

Acronym: ADVANCE-EU

Important dates

Study start: 2014
Primary completion: 2014
Study completion: 2014
First posted: Feb 12, 2014
Registry last updated: Dec 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed