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

NCT ID: NCT02060682

Last Updated: 2019-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-02-28

Study Completion Date

2014-07-31

Brief Summary

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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

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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.

Conditions

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Coronary Artery Disease

Keywords

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Fractional Flow Reserve Rapid Exchange Catheter

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Navvus Catheter FFR

Intervention Type 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).

Interventions

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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).

Intervention Type DEVICE

Eligibility Criteria

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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

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Acist Medical Systems

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thierry Lefèvre, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Privé Jacques Cartier

Locations

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Hospital Privé Jacques Cartier

Massy, , France

Site Status

Centre Cardiologique du Nord

Saint-Denis, , France

Site Status

Johann Wolfgang Goethe Universität

Frankfurt, , Germany

Site Status

Klinikum Fulda gAG

Fulda, , Germany

Site Status

Universitätsmedizin der Johannes Gutenberg-Universität Mainz

Mainz, , Germany

Site Status

Ospedale San Raffaele

Milan, , Italy

Site Status

Hospital Universitario San Juan de Alicante

Alicante, , Spain

Site Status

Countries

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France Germany Italy Spain

Other Identifiers

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EU100

Identifier Type: -

Identifier Source: org_study_id