Advancing Cath Lab Results With FFRangio Coronary Physiology Assessment

Running, not enrolling · Not applicable

Conditions studied: Percutaneous Coronary Intervention

In brief

To test whether FFRangio-guided treatment is non-inferior to conventional pressure wire-guided treatment in patients with coronary artery disease.

Key facts

Study ID

NCT05893498

Run by

CathWorks Ltd.

People needed

1924

Starts

2023-06-21

Expected to finish

2026-05-01

Last updated by the study team

2026-03-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult patients (≥18 years of age) with one or more study lesion(s) (diameter stenosis 50-90%) deemed appropriate for both pressure-wire and FFRangio physiologic assessment.
• General Exclusion Criteria:
• Subject with ST-elevation (MI (STEMI) within 72 hours at time of study enrollment
• Prior coronary artery bypass graft (CABG) with patent grafts to the study vessel(s)
• Patients undergoing coronary physiologic assessment where one possible outcome is referral for CABG
• The study vessel supplies a significant nonviable territory (e.g., prior transmural MI)
• Severe left sided valvular heart disease
• Most recent documented LVEF ≤30%
• Women who are pregnant or breastfeeding (women of childbearing potential are required to have negative pregnancy test within 1 week of index procedure)
• Patients with life expectancy <1 year life as estimated by treating physician.
• Subjects enrolled in other ongoing non-registry clinical studies that would impact conduct or outcomes of this study (registries and long-term follow-up of other studies are allowed)
• Subjects who have undergone angiographic or wire-based coronary physiological assessment for 1 or more potential study lesions within 30 days of enrollment.
• Angiographic Exclusion Criteria:
• Coronary angiogram is not acquired per instructions as defined in the Study Protocol
• Sthe study lesion is the clear culprit for a NSTEACS
• Angiographic evidence of a procedural complication (e.g., acute stent thrombosis, flow-limiting dissection, perforation, slow/no reflow, or other) prior to randomization
• Thrombolysis in myocardial infarction (TIMI) Grade 2 flow or lower in any study vessel at time of enrollment
• The study vessel is in a left coronary vessel with separate left anterior descending and left circumflex ostia arising from the aorta
• The study lesion involves the left main coronary artery (stenosis ≥ 50%)
• The study lesion is in an ectatic or aneurysmal coronary segment (defined as lumen diameter 1.5x diameter or the reference vessel)

Where it is running

• Hopitaux Universitaires Geneve (HUG) — Geneva, Switzerland
• centre hospitalier universitaire vaudois (CHUV) — Lausanne, Switzerland
• Hôpital Cantonal de Fribourg (HFR) — Villars-sur-Glâne, Switzerland
• Basildon University Hospital — Basildon, United Kingdom
• Imperial College Healthcare — London, United Kingdom
• Musgrove Park Hospital — Taunton, United Kingdom
• Chibanishi General Hospital — Matsudo, Japan
• Mie University Hospital — Osaka, Japan
• University of California San Diego Health — La Jolla, California, United States
• VA- Long Beach Healthcare — Long Beach, California, United States
• Keck Medicine of USC — Los Angeles, California, United States
• UCLA Medical Center — Los Angeles, California, United States
• Stanford University — Palo Alto, California, United States
• VA - Palo Alto Healthcare — Palo Alto, California, United States
• Kaiser Permanente San Francisco — San Francisco, California, United States
• St. Joesph's Medical Center — Stockton, California, United States
• HCA Florida JFK Hospital — Atlantis, Florida, United States
• Cardiac & Vascular Institute — Gainesville, Florida, United States
• University of Miami — Miami, Florida, United States
• HCA Florida Northside Hospital — St. Petersburg, Florida, United States
• Tallahassee Research Institute — Tallahassee, Florida, United States
• University of South Florida — Tampa, Florida, United States
• Archbold Hospital — Thomasville, Georgia, United States
• Carle Foundation Hospital — Urbana, Illinois, United States
• Sakakibara Heart Institute — Tokyo, Japan

Full record on ClinicalTrials.gov

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