Advancing Cath Lab Results With FFRangio Coronary Physiology Assessment
NCT ID: NCT05893498
Last Updated: 2025-01-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
1924 participants
INTERVENTIONAL
2023-06-21
2026-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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FFRangio
FFRangio guided revascularization
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.
Pressure wire
Pressure wire-based guided revascularization (FFR or NHPR)
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).
Interventions
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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).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
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.
18 Years
ALL
No
Sponsors
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Cardiovascular Research Foundation, New York
OTHER
CathWorks Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Ajay J Kirtane, MD, SM
Role: STUDY_CHAIR
NewYork-Presbyterian/Columbia University Irving Medical Center
William F Fearon, MD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Allen Jeremias, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
St. Francis Hospital & Heart Center
Martin B Leon, MD
Role: STUDY_CHAIR
NewYork-Presbyterian/Columbia University Irving Medical Center
Locations
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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
MedStar Health Research Institute
Washington D.C., District of Columbia, United States
HCA Florida JFK Hospital
Atlantis, Florida, United States
Cardiac & Vascular Institute
Gainesville, Florida, United States
HCA Florida Largo Hospital
Largo, Florida, United States
HCA Florida Northside Hospital
St. Petersburg, Florida, United States
Tallahassee Research Institute
Tallahassee, 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
Rabin Medical Centre
Petah Tikva, , Israel
Gifu Heart Center
Gifu, , Japan
Kobe University
Kobe, , Japan
Mie University Hospital
Osaka, , Japan
Sakakibara Heart Institute
Tokyo, , Japan
Hopitaux Universitaires Geneve (HUG)
Geneva, , Switzerland
centre hospitalier universitaire vaudois (CHUV)
Lausanne, , Switzerland
Imperial College Healthcare
London, , United Kingdom
Countries
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References
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Redfors B, Madhavan MV, Kirtane AJ, Fearon WF, Yeh RW, Cohen DJ, Al-Lamee R, Jeremias A, Witberg G, Sharma RP, Popma A, Kaki A, Froimovich A, Leon MB. FFRangio-guided versus pressure wire-guided PCI: design and rationale of the multicentre, randomised ALL-RISE trial. EuroIntervention. 2025 Aug 18;21(16):961-969. doi: 10.4244/EIJ-D-25-00200.
Other Identifiers
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CathWorks CWX-08
Identifier Type: -
Identifier Source: org_study_id
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