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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Thierry Lefèvre, MD | Hospital Privé Jacques Cartier | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Privé Jacques Cartier | Massy | France | ||||
| Centre Cardiologique du Nord |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Saint-Denis |
| France |
| Johann Wolfgang Goethe Universität | Frankfurt | Germany |
| Klinikum Fulda gAG | Fulda | Germany |
| Universitätsmedizin der Johannes Gutenberg-Universität Mainz | Mainz | Germany |
| Ospedale San Raffaele | Milan | Italy |
| Hospital Universitario San Juan de Alicante | Alicante | Spain |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |