Assessment of Catheter-based Interrogation and Standard Techniques for Fractional Flow Reserve Measurement
Trial ID or NCT#
NCT02577484
Status
NOT RECRUITING
Purpose
This study will assess the differences between Fractional Flow Reserve (FFR) measurements made by the Navvus catheter and a commercially available pressure guidewire in up to 240 subjects where FFR is clinically indicated. All subjects will receive diagnostic treatment according to clinical indications and center standard practice.
Official Title
Assessment of Catheter-based Interrogation and Standard Techniques for Fractional Flow Reserve Measurement: the ACIST-FFR Study
Eligibility Criteria
Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes
Inclusion Criteria:
- * Subject is 18 years of age or older* Subject has a clinical indication for coronary angiography* Subject or subject's legal representative has the ability to understand and provide signed consent for participating in the study
- Angiographic Inclusion Criteria:
- * Vessel has a TIMI flow = 3* Subject has de novo lesion which physician has determined has a clinical indication for FFR measurement* RVD of the target lesion is assessed by the operator to be ≥2.25 mm.
- General
Exclusion Criteria:
- * Subjects with acute ST-elevation or non-ST-elevation myocardial infarction as the indication for coronary angiography* NYHA Class 4 severe heart failure
- Angiographic Exclusion Criteria:
- * Target vessel has angiographically visible or suspected thrombus.* Target lesion is within a bypass graft.* Angiographic evidence of a dissection prior to initiation of PW measurements.* Target vessel contains excessive tortuosity or calcification.
Investigator(s)
William Fearon, MD
Interventional cardiologist,
Cardiologist
Professor of Medicine (Cardiovascular Medicine)
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