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NCT02060682 Clinical Trial

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

Coronary Artery Disease Clinical Trial

— ADVANCE-EU  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02060682
Other study ID # EU100
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 2014
Est. completion date July 2014

Study information
Verified date December 2019
Source Acist Medical Systems
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date July 2014
Est. primary completion date July 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

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).

Locations
Country Name City State
France Hospital Privé Jacques Cartier Massy
France Centre Cardiologique du Nord St. Denis
Germany Johann Wolfgang Goethe Universität Frankfurt
Germany Klinikum Fulda gAG Fulda
Germany Universitätsmedizin der Johannes Gutenberg-Universität Mainz Mainz
Italy Ospedale San Raffaele Milan
Spain Hospital Universitario San Juan de Alicante Alicante

Sponsors (1)
Lead Sponsor Collaborator
Acist Medical Systems

Countries where clinical trial is conducted

France,  Germany,  Italy,  Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Procedural Success 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. From enrollment through hospital discharge, an expected average of 1 day.
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