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

NCT02060682 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2019-12-09

No results posted yet for this study

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

Interventions

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).

Sponsors & Collaborators

  • Acist Medical Systems

    lead INDUSTRY

Principal Investigators

  • Thierry Lefèvre, MD · Hospital Privé Jacques Cartier

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2014-07-31
Completion
2014-07-31

Countries

  • France
  • Germany
  • Italy
  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02060682 on ClinicalTrials.gov