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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Acist Medical Systems
ClinicalTrials.gov Identifier:
NCT02060682
First received: February 7, 2014
Last updated: July 15, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Coronary Artery Disease
Device: Navvus Catheter FFR

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: Post-Market Registry of the ACIST Cardiovascular Pressure Measurement (CPM) System and Navvus Catheter in Clinical Practice-ADVANCE-EU

Further study details as provided by Acist Medical Systems:

Primary Outcome Measures:
  • Procedural Success [ Time Frame: From enrollment through hospital discharge, an expected average of 1 day. ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 60
Study Start Date: February 2014
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
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).

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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:

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02060682

Locations
France
Hospital Privé Jacques Cartier
Massy, France
Centre Cardiologique du Nord
St. Denis, France
Germany
Johann Wolfgang Goethe Universität
Frankfurt, Germany
Klinikum Fulda gAG
Fulda, Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, Germany
Italy
Ospedale San Raffaele
Milan, Italy
Spain
Hospital Universitario San Juan de Alicante
Alicante, Spain
Sponsors and Collaborators
Acist Medical Systems
Investigators
Principal Investigator: Thierry Lefèvre, MD Hospital Privé Jacques Cartier
  More Information

No publications provided

Responsible Party: Acist Medical Systems
ClinicalTrials.gov Identifier: NCT02060682     History of Changes
Other Study ID Numbers: EU100
Study First Received: February 7, 2014
Last Updated: July 15, 2014
Health Authority: Germany: Ethics Commission
France: French Data Protection Authority
Italy: Ethics Committee
Spain: Ethics Committee

Keywords provided by Acist Medical Systems:
Fractional Flow Reserve
Rapid Exchange
Catheter

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014