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ACTIVE NOT RECRUITING

NCT05893498

Advancing Cath Lab Results With FFRangio Coronary Physiology Assessment

Sponsor: CathWorks Ltd.

View on ClinicalTrials.gov

Summary

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1924

Start Date

2023-06-21

Completion Date

2026-05

Last Updated

2026-03-10

Healthy Volunteers

Conditions

Percutaneous Coronary Intervention

Interventions

DEVICE

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.

DEVICE

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).

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)

Locations (59)

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

Ascension Via Christi St. Francis

Wichita, Kansas, United States

Kansas Heart Hospital

Wichita, Kansas, United States

St. Elizabeth Healthcare

Edgewood, Kentucky, United States

Medstar Union Memorial Hospital

Baltimore, Maryland, United States

TidalHealth, INC

Salisbury, Maryland, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Ascension St. John Hospital

Detroit, Michigan, United States

Metropolitan Heart Vascular Institute

Coon Rapids, Minnesota, United States

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, United States

Cardiac Associates Research

Tupelo, Mississippi, United States

Mountainside Medical Center

Montclair, New Jersey, United States

Morristown Medical Center

Morristown, New Jersey, United States

The Valley Hospital

Ridgewood, New Jersey, United States

New York Presbyterian Methodist Hospital

Brooklyn, New York, United States

NYU Langone Health

New York, New York, United States

Columbia University Medical Center / New York Presbyterian Hospital

New York, New York, United States

New York Presbyterian / Weill Cornell Medical Center

New York, New York, United States

Northwell Health (Lenox Hill, North Shore, South Shore, Huntington, Staten Island))

New York, New York, United States

St. Francis Hospital and Heart Center

Roslyn, New York, United States

Ellis Hospital

Schenectady, New York, United States

The Christ Hospital

Cincinnati, Ohio, United States

Mount Carmel Health System

Columbus, Ohio, United States

Lehigh Valley Health

Allentown, Pennsylvania, United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Baylor Scott & White The Heart Hospital - Plano

Plano, Texas, United States

HCA Methodist Healthcare of San Antonio

San Antonio, Texas, United States

Inova Fairfax Hospital

Fairfax, Virginia, United States

Golda HaSharon Hospital

Petah Tikva, Israel

Rabin Medical Centre

Petah Tikva, Israel

Fukuyama Cardiovascular Hospital

Fukuyama, Japan

Gifu Heart Center

Gifu, Japan

Ichinomiyanishi Hospital

Ichinomiya, Japan

Kobe University

Kobe, Japan

Chibanishi General Hospital

Matsudo, Japan

Mie University Hospital

Osaka, Japan

NTT Medical Center Tokyo

Tokyo, Japan

Sakakibara Heart Institute

Tokyo, Japan

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

Clinical Research Directory

Advancing Cath Lab Results With FFRangio Coronary Physiology Assessment

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (59)