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Clinical Trials in the UK / NCT05893498
Active, not recruiting Not applicable

Advancing Cath Lab Results With FFRangio Coronary Physiology Assessment

NCT05893498 · tracked via the Priya Life Science UK tracker
Sponsor
CathWorks Ltd.
Phase
Not applicable
Started
2023-06-21
Last updated
2026-03-10

Condition(s) studied

Percutaneous Coronary Intervention

Investigational drug(s) / intervention(s)

FFRangioFFR or NHPR

FFRangio: A 3D image-base software device (CathWorks, Ltd, Kfar Saba, Israel) using three (3) angiographic views to provide a quantitative analysis of the functional significance of coronary lesions.

FFR or NHPR: Using an invasive pressure-wire to assess functional significance of coronary lesions either under hyperemic conditions (FFR) or utilizing Non-hyperemic pressure ratios (NHPR).

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1\. 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: 1. Subject with ST-elevation (MI (STEMI) within 72 hours at time of study enrollment 2. Prior coronary artery bypass graft (CABG) with patent grafts to the study vessel(s) 3. Patients undergoing coronary physiologic assessment where one possible outcome is referral for CABG 4. The study vessel supplies a significant nonviable territory (e.g., prior transmural MI) 5. Severe left sided valvular heart disease 6. Most recent documented LVEF ≤30% 7. Women who are pregnant or breastfeeding (women of childbearing potential are required to have negative pregnancy test within 1 week of index procedure) 8. Patients with life expectancy \<1 year life as estimated by treating physician. 9. 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) 10. 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: 1. Coronary angiogram is not acquired per instructions as defined in the Study Protocol 2. Sthe study lesion is the clear culprit for a NSTEACS 3. Angiographic evidence of a procedural complication (e.g., acute stent thrombosis, flow-limiting dissection, perforation, slow/no reflow, or other) prior to randomization 4. Thrombolysis in myocardial infarction (TIMI) Grade 2 flow or lower in any study vessel at time of enrollment 5. The study vessel is in a left coronary vessel with separate left anterior descending and left circumflex ostia arising from the aorta 6. The study lesion involves the left main coronary artery (stenosis ≥ 50%) 7. The study lesion is in an ectatic or aneurysmal coronary segment (defined as lumen diameter 1.5x diameter or the reference vessel)

Primary outcome measure(s)

Trial sites (59)

FacilityCityRegionStatus
University of California San Diego Health La Jolla California
VA- Long Beach Healthcare Long Beach California
Keck Medicine of USC Los Angeles California
UCLA Medical Center Los Angeles California
Stanford University Palo Alto California
VA - Palo Alto Healthcare Palo Alto California
Kaiser Permanente San Francisco San Francisco California
St. Joesph's Medical Center Stockton California
HCA Florida JFK Hospital Atlantis Florida
Cardiac & Vascular Institute Gainesville Florida
University of Miami Miami Florida
HCA Florida Northside Hospital St. Petersburg Florida
Tallahassee Research Institute Tallahassee Florida
University of South Florida Tampa Florida
Archbold Hospital Thomasville Georgia
Carle Foundation Hospital Urbana Illinois
Ascension Via Christi St. Francis Wichita Kansas
Kansas Heart Hospital Wichita Kansas
St. Elizabeth Healthcare Edgewood Kentucky
Medstar Union Memorial Hospital Baltimore Maryland
TidalHealth, INC Salisbury Maryland
Beth Israel Deaconess Medical Center Boston Massachusetts
Ascension St. John Hospital Detroit Michigan
Metropolitan Heart Vascular Institute Coon Rapids Minnesota
Minneapolis Heart Institute Foundation Minneapolis Minnesota
Cardiac Associates Research Tupelo Mississippi
Mountainside Medical Center Montclair New Jersey
Morristown Medical Center Morristown New Jersey
The Valley Hospital Ridgewood New Jersey
New York Presbyterian Methodist Hospital Brooklyn New York
NYU Langone Health New York New York
Columbia University Medical Center / New York Presbyterian Hospital New York New York
New York Presbyterian / Weill Cornell Medical Center New York New York
Northwell Health (Lenox Hill, North Shore, South Shore, Huntington, Staten Island)) New York New York
St. Francis Hospital and Heart Center Roslyn New York
Ellis Hospital Schenectady New York
The Christ Hospital Cincinnati Ohio
Mount Carmel Health System Columbus Ohio
Lehigh Valley Health Allentown Pennsylvania
Hospital of the University of Pennsylvania Philadelphia Pennsylvania

+ 19 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05893498 on ClinicalTrials.gov ↗ ← All trials in the UK