Trial Search Results
Assessment of Catheter-based Interrogation and Standard Techniques for Fractional Flow Reserve Measurement
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.
Stanford is currently not accepting patients for this trial.
Acist Medical Systems
- Device: RXi System
- Device: Pressure Wire
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.
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study