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.

Lead Sponsor:

Acist Medical Systems

Stanford Investigator(s):

Intervention(s):

  • Device: RXi System
  • Device: Pressure Wire

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.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Not Recruiting