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Assessment of Catheter-based Interrogation and Standard Techniques for Fractional Flow Reserve Measurement
Not Recruiting
Trial ID: NCT02577484
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
Stanford Investigator(s)
William Fearon, MD
Professor of Medicine (Cardiovascular Medicine)
Eligibility
General 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.
Intervention(s):
device: RXi System
device: Pressure Wire
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305