Advancing Cath Lab Results With FFRangio Coronary Physiology Assessment (ALL-RISE)

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

Study Overview

• Status: Active, not recruiting
• Conditions: Percutaneous Coronary Intervention
• Intervention / Treatment: Device: FFRangio; Device: FFR or NHPR

Detailed Description

ALL-RISE is a prospective, randomized, multi-center, controlled post-market study. The ALL-RISE study is designed to test whether FFRangio-guided treatment is non-inferior to conventional pressure wire-guided treatment in patients with coronary artery disease being evaluated for percutaneous coronary intervention (PCI) with respect to major adverse cardiac events (MACE) at one year.

• Study Type: Interventional
• Enrollment (Estimated): 1924
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Petah Tikva, Israel, 49372
    • Golda HaSharon Hospital
  • Petah Tikva, Israel, 4941492
    • Rabin Medical Centre
• Japan
  • Fukuyama, Japan
    • Fukuyama Cardiovascular Hospital
  • Gifu, Japan
    • Gifu Heart Center
  • Ichinomiya, Japan
    • Ichinomiyanishi Hospital
  • Kobe, Japan
    • Kobe University
  • Matsudo, Japan
    • Chibanishi General Hospital
  • Osaka, Japan
    • Mie University Hospital
  • Tokyo, Japan
    • Sakakibara Heart Institute
  • Tokyo, Japan
    • NTT Medical Center Tokyo
• Switzerland
  • Geneva, Switzerland
    • Hopitaux Universitaires Geneve (HUG)
  • Lausanne, Switzerland, CH-1011
    • Centre Hospitalier Universitaire Vaudois (CHUV)
  • Villars-sur-Glâne, Switzerland
    • Hôpital Cantonal de Fribourg (HFR)
• United Kingdom
  • Basildon, United Kingdom
    • Basildon University Hospital
  • London, United Kingdom, W12 0HS
    • Imperial College Healthcare
  • Taunton, United Kingdom
    • Musgrove Park Hospital
• United States
  • California
    • La Jolla, California, United States, 92037
      • University of California San Diego Health
    • Long Beach, California, United States, 90822
      • VA- Long Beach Healthcare
    • Los Angeles, California, United States, 90095
      • UCLA Medical Center
    • Los Angeles, California, United States, 90033
      • Keck Medicine of USC
    • Palo Alto, California, United States, 94305
      • Stanford University
    • Palo Alto, California, United States, 94305
      • VA - Palo Alto Healthcare
    • San Francisco, California, United States, 94118
      • Kaiser Permanente San Francisco
    • Stockton, California, United States, 95204
      • St. Joesph's Medical Center
  • Florida
    • Atlantis, Florida, United States, 33462
      • HCA Florida JFK Hospital
    • Gainesville, Florida, United States, 32605
      • Cardiac & Vascular Institute
    • Miami, Florida, United States, 33136
      • University of Miami
    • St. Petersburg, Florida, United States, 33709
      • HCA Florida Northside Hospital
    • Tallahassee, Florida, United States, 32308
      • Tallahassee Research Institute
    • Tampa, Florida, United States, 33606
      • University of South Florida
  • Georgia
    • Thomasville, Georgia, United States, 31792
      • Archbold Hospital
  • Illinois
    • Urbana, Illinois, United States, 61801
      • Carle Foundation Hospital
  • Kansas
    • Wichita, Kansas, United States, 67226
      • Kansas Heart Hospital
    • Wichita, Kansas, United States, 67214
      • Ascension Via Christi St. Francis
  • Kentucky
    • Edgewood, Kentucky, United States, 41017
      • St. Elizabeth Healthcare
  • Maryland
    • Baltimore, Maryland, United States, 21218
      • MedStar Union Memorial Hospital
    • Salisbury, Maryland, United States, 21801
      • TidalHealth, INC
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
  • Michigan
    • Detroit, Michigan, United States, 48236
      • Ascension St. John Hospital
  • Minnesota
    • Coon Rapids, Minnesota, United States, 55433
      • Metropolitan Heart Vascular Institute
    • Minneapolis, Minnesota, United States, 55407
      • Minneapolis Heart Institute Foundation
  • Mississippi
    • Tupelo, Mississippi, United States, 38801
      • Cardiac Associates Research
  • New Jersey
    • Montclair, New Jersey, United States, 07042
      • Mountainside Medical Center
    • Morristown, New Jersey, United States, 07960
      • Morristown Medical Center
    • Ridgewood, New Jersey, United States, 07450
      • The Valley Hospital
  • New York
    • Brooklyn, New York, United States, 11215
      • New York Presbyterian Methodist Hospital
    • New York, New York, United States, 10016
      • NYU Langone Health
    • New York, New York, United States, 10032
      • Columbia University Medical Center / New York Presbyterian Hospital
    • New York, New York, United States, 10065
      • New York Presbyterian / Weill Cornell Medical Center
    • New York, New York, United States, 10075
      • Northwell Health (Lenox Hill, North Shore, South Shore, Huntington, Staten Island))
    • Roslyn, New York, United States, 11576
      • St. Francis Hospital and Heart Center
    • Schenectady, New York, United States, 12308
      • Ellis Hospital
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • The Christ Hospital
    • Columbus, Ohio, United States, 43219
      • Mount Carmel Health System
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18103
      • Lehigh Valley Health
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania
  • Texas
    • Plano, Texas, United States, 75093
      • Baylor Scott & White The Heart Hospital - Plano
    • San Antonio, Texas, United States, 78249
      • HCA Methodist Healthcare of San Antonio
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Inova Fairfax Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FFRangio; FFRangio guided revascularization	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.
Active Comparator: Pressure wire; Pressure wire-based guided revascularization (FFR or NHPR)	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).; Other Names: FFR, iFR RFR, dPR, Pd/Pa

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MACE	Rate of the composite of all-cause death, myocardial infarction (MI) or unplanned clinically-driven revascularization	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-Cause Mortality	Total rate of death from any cause	12 months
Myocardial Infarction	Total rate of myocardial infarction	12 months
Unplanned Revascularization	Total rate of unplanned clinically-driven revascularization	12 months
Stent thrombosis	Total rate of definite or probable stent thrombosis	12 months
Peri-Procedural Complications	Rate of peri-procedural complications defined as angiographic complications in the study vessel.	30 Days
Stroke	Rate of disabling stroke	30 Days
Bleeding	Rate of Major bleeding	30 Days
Kidney Injury	Rate of Acute kidney injury (AKI)	30 Days
Patient Reported Health Status - SAQ-7	Seattle Angina Questionnaire (SAQ-7)	Baseline, Day 30 and 12 Months
Patient Reported Quality of Life - EQ-5D	EuroQol Group EQ-5D-5L	Baseline, Day 30 and 12 Months
Procedure Time	Total time from arterial access to removal of last catheter in minutes	24 hours
Contrast Dose	Total amount of contrast used in ml	24 hours
Radiation Dose	Total amount of radiation in Gy	24 hours
Resource utilization	Hospital costs will be assessed for all patients based on procedural and index hospitalization resource utilization and standard US costs for each resource (including procedural time).	24 hours
Cost-effectiveness	Cumulative healthcare cost in dollars for every major adverse event avoided	12 Months
FFRangio Usability	Ability to conduct the FFRangio assessment without any system malfunction	24 hours
Pressure Wire Usability	Ability to conduct the pressure wire based assessment without any system malfunction	24 hours

Collaborators and Investigators

• Sponsor: CathWorks Ltd.
• Collaborators: Cardiovascular Research Foundation, New York
• Investigators: Principal Investigator: William F Fearon, MD, Stanford University; Study Chair: Ajay J Kirtane, MD, SM, NewYork-Presbyterian/Columbia University Irving Medical Center; Principal Investigator: Allen Jeremias, MD, MSc, St. Francis Hospital & Heart Center; Study Chair: Martin B Leon, MD, NewYork-Presbyterian/Columbia University Irving Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2023
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: April 25, 2023
• First Submitted That Met QC Criteria: May 29, 2023
• First Posted (Actual): June 8, 2023

Study Record Updates

• Last Update Posted (Actual): March 10, 2026
• Last Update Submitted That Met QC Criteria: March 9, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: PCI; Coronary Artery Disease; FFRangio; Pressure Wire-Guided
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease
• Other Study ID Numbers: CathWorks CWX-08

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No