FFRangio Accuracy vs. Standard FFR (FAST-FFR)

CathWorks

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Device: FFRangio

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT03226262

CWX-03

Details and patient eligibility

About

This is a prospective, observational, multi-center, single-arm, clinical trial designed to assess the efficacy of FFRangio in measuring FFR obtained from angiography compared to Invasive FFR for diagnosing hemodynamically significant coronary stenosis.

Enrollment: 382 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male or female subjects, >18 years of age.
• Patients with stable angina or unstable angina or NSTEMI, and in whom invasive FFR is being assessed in a non-culprit stenosis in at least one coronary artery.
• Subject is undergoing invasive FFR with Adenosine, ATP or Papaverine used as hyperemic stimulus.
• Provides written, informed consent (where required)

Exclusion criteria

• Contraindication for FFR examination or administration of vasodilators.
• Subject is presenting with acute infarct (STEMI) OR has documented prior STEMI on same side (right/left).
• CTO in target vessel.
• Prior CABG, heart transplant or valve surgery, or prior TAVI/TAVR.
• Known LVEF ≤45%.
• Arteries supplying akinetic or severe hypokinetic territories if already known based on prior imaging.
• TIMI Grade 2 or lower at baseline.
• Target lesion involves Left Main (stenosis >50%).
• PCI with stent in target vessel in past 12 months, or target vessel involves in-stent restenosis.
• Severe, diffuse disease defined as the presence of diffuse, serial gross luminal irregularities present in the majority of the coronary tree.
• Target coronary vessel is supplied by major collaterals.