Advancing Cath Lab Results With FFRangio Coronary Physiology Assessment
ALL-RISE
1 other identifier
interventional
1,924
5 countries
59
Brief Summary
To test whether FFRangio-guided treatment is non-inferior to conventional pressure wire-guided treatment in patients with coronary artery disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2023
Typical duration for not_applicable
59 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 25, 2023
CompletedFirst Posted
Study publicly available on registry
June 8, 2023
CompletedStudy Start
First participant enrolled
June 21, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2026
CompletedMarch 10, 2026
March 1, 2026
2.9 years
April 25, 2023
March 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
MACE
Rate of the composite of all-cause death, myocardial infarction (MI) or unplanned clinically-driven revascularization
1 year
Secondary Outcomes (17)
All-Cause Mortality
12 months
Myocardial Infarction
12 months
Unplanned Revascularization
12 months
Stent thrombosis
12 months
Peri-Procedural Complications
30 Days
- +12 more secondary outcomes
Study Arms (2)
FFRangio
EXPERIMENTALFFRangio guided revascularization
Pressure wire
ACTIVE COMPARATORPressure wire-based guided revascularization (FFR or NHPR)
Interventions
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.
Using an invasive pressure-wire to assess functional significance of coronary lesions either under hyperemic conditions (FFR) or utilizing Non-hyperemic pressure ratios (NHPR).
Eligibility Criteria
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.
You may not qualify if:
- 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.
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CathWorks Ltd.lead
- Cardiovascular Research Foundation, New Yorkcollaborator
Study Sites (59)
University of California San Diego Health
La Jolla, California, 92037, United States
VA- Long Beach Healthcare
Long Beach, California, 90822, United States
Keck Medicine of USC
Los Angeles, California, 90033, United States
UCLA Medical Center
Los Angeles, California, 90095, United States
Stanford University
Palo Alto, California, 94305, United States
VA - Palo Alto Healthcare
Palo Alto, California, 94305, United States
Kaiser Permanente San Francisco
San Francisco, California, 94118, United States
St. Joesph's Medical Center
Stockton, California, 95204, United States
HCA Florida JFK Hospital
Atlantis, Florida, 33462, United States
Cardiac & Vascular Institute
Gainesville, Florida, 32605, United States
University of Miami
Miami, Florida, 33136, United States
HCA Florida Northside Hospital
St. Petersburg, Florida, 33709, United States
Tallahassee Research Institute
Tallahassee, Florida, 32308, United States
University of South Florida
Tampa, Florida, 33606, United States
Archbold Hospital
Thomasville, Georgia, 31792, United States
Carle Foundation Hospital
Urbana, Illinois, 61801, United States
Ascension Via Christi St. Francis
Wichita, Kansas, 67214, United States
Kansas Heart Hospital
Wichita, Kansas, 67226, United States
St. Elizabeth Healthcare
Edgewood, Kentucky, 41017, United States
Medstar Union Memorial Hospital
Baltimore, Maryland, 21218, United States
TidalHealth, INC
Salisbury, Maryland, 21801, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Ascension St. John Hospital
Detroit, Michigan, 48236, United States
Metropolitan Heart Vascular Institute
Coon Rapids, Minnesota, 55433, United States
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407, United States
Cardiac Associates Research
Tupelo, Mississippi, 38801, United States
Mountainside Medical Center
Montclair, New Jersey, 07042, United States
Morristown Medical Center
Morristown, New Jersey, 07960, United States
The Valley Hospital
Ridgewood, New Jersey, 07450, United States
New York Presbyterian Methodist Hospital
Brooklyn, New York, 11215, United States
NYU Langone Health
New York, New York, 10016, United States
Columbia University Medical Center / New York Presbyterian Hospital
New York, New York, 10032, United States
New York Presbyterian / Weill Cornell Medical Center
New York, New York, 10065, United States
Northwell Health (Lenox Hill, North Shore, South Shore, Huntington, Staten Island))
New York, New York, 10075, United States
St. Francis Hospital and Heart Center
Roslyn, New York, 11576, United States
Ellis Hospital
Schenectady, New York, 12308, United States
The Christ Hospital
Cincinnati, Ohio, 45219, United States
Mount Carmel Health System
Columbus, Ohio, 43219, United States
Lehigh Valley Health
Allentown, Pennsylvania, 18103, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Baylor Scott & White The Heart Hospital - Plano
Plano, Texas, 75093, United States
HCA Methodist Healthcare of San Antonio
San Antonio, Texas, 78249, United States
Inova Fairfax Hospital
Fairfax, Virginia, 22031, United States
Golda HaSharon Hospital
Petah Tikva, 49372, Israel
Rabin Medical Centre
Petah Tikva, 4941492, 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, CH-1011, Switzerland
Hôpital Cantonal de Fribourg (HFR)
Villars-sur-Glâne, Switzerland
Basildon University Hospital
Basildon, United Kingdom
Imperial College Healthcare
London, W12 0HS, United Kingdom
Musgrove Park Hospital
Taunton, United Kingdom
Related Publications (2)
Fearon WF, Jeremias A, Witberg G, Al-Lamee R, Cohen DJ, Kaki A, Sharma RP, Yeh RW, Chehab BM, Kim MC, Otake H, Tayal R, Matsuo H, McEntegart M, Patel AK, Sandoval Y, Al-Azizi KM, Dan K, Razzouk L, Fournier S, Popma A, Popma JJ, Zhao D, Redfors B, Madhavan MV, Kornowski R, Leon MB, Kirtane AJ; ALL-RISE Investigators. Angiography-Derived Fractional Flow Reserve to Guide PCI. N Engl J Med. 2026 Mar 29. doi: 10.1056/NEJMoa2600949. Online ahead of print.
PMID: 41910384DERIVEDRedfors 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.
PMID: 40828315DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Ajay J Kirtane, MD, SM
NewYork-Presbyterian/Columbia University Irving Medical Center
- PRINCIPAL INVESTIGATOR
William F Fearon, MD
Stanford University
- PRINCIPAL INVESTIGATOR
Allen Jeremias, MD, MSc
St. Francis Hospital & Heart Center
- STUDY CHAIR
Martin B Leon, MD
NewYork-Presbyterian/Columbia University Irving Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 25, 2023
First Posted
June 8, 2023
Study Start
June 21, 2023
Primary Completion
May 1, 2026
Study Completion
May 1, 2026
Last Updated
March 10, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share