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

NCT02060682 | Completed

• 1 other identifier: EU100
• Study Type: observational
• Target: 60
• Locations: 4 countries
• Sites: 7

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.

Conditions

Coronary Artery Disease

Keywords

Fractional Flow Reserve; Rapid Exchange; Catheter

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

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.

Device: Navvus Catheter FFR

Interventions

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).

Navvus Catheter FFR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects 18 years of age or older, in whom FFR measurement is indicated to guide PCI strategy and use of the ACIST CPM System and Navvus Catheter is attempted.

You may qualify if:

• 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.

Sponsors & Collaborators

• Acist Medical Systems: lead

Study Sites (7)

Hospital Privé Jacques Cartier

Massy, France

Location

Centre Cardiologique du Nord

Saint-Denis, France

Location

Johann Wolfgang Goethe Universität

Frankfurt, Germany

Location

Klinikum Fulda gAG

Fulda, Germany

Location

Universitätsmedizin der Johannes Gutenberg-Universität Mainz

Mainz, Germany

Location

Ospedale San Raffaele

Milan, Italy

Location

Hospital Universitario San Juan de Alicante

Alicante, Spain

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Thierry Lefèvre, MD

  Hospital Privé Jacques Cartier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2014
• First Posted: February 12, 2014
• Study Start: February 1, 2014
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: December 9, 2019

Record last verified: 2019-12

Locations

IT (1); ES (1); FR (2); DE (3)