Advancing Cath Lab Results With FFRangio Coronary Physiology Assessment

Last updated: January 22, 2025
Sponsor: CathWorks Ltd.
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Open Heart Surgery

Treatment

FFR or NHPR

FFRangio

Clinical Study ID

NCT05893498
CathWorks CWX-08
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Adult patient ( ≥18 years old) presenting with CCS or NSTEACS with one or more studylesion(s) deemed appropriate (diameter stenosis 50-90%) for both pressure-wire andFFRangio physiologic assessment.

Exclusion

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 isreferral for CABG

  4. The study vessel supplies a significant nonviable territory (e.g., prior transmuralMI)

  5. Severe left sided valvular heart disease

  6. Most recent documented LVEF ≤30%

  7. Women who are pregnant or breastfeeding (women of childbearing potential arerequired 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 impactconduct or outcomes of this study (registries and long-term follow-up of otherstudies are allowed)

  10. Subjects who have undergone angiographic or wire-based coronary physiologicalassessment for 1 or more potential study lesions within 30 days of enrollment.

Study Design

Total Participants: 1924
Treatment Group(s): 2
Primary Treatment: FFR or NHPR
Phase:
Study Start date:
June 21, 2023
Estimated Completion Date:
January 31, 2026

Study 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.

Connect with a study center

  • Rabin Medical Centre

    Petah-Tikva, 4941492
    Israel

    Site Not Available

  • Gifu Heart Center

    Gifu,
    Japan

    Site Not Available

  • Kobe University

    Kobe City,
    Japan

    Site Not Available

  • Mie University Hospital

    Osaka,
    Japan

    Site Not Available

  • Sakakibara Heart Institute

    Tokyo,
    Japan

    Site Not Available

  • Hopitaux Universitaires Geneve (HUG)

    Geneva,
    Switzerland

    Site Not Available

  • centre hospitalier universitaire vaudois (CHUV)

    Lausanne, CH-1011
    Switzerland

    Site Not Available

  • Imperial College Healthcare

    London, W12 0HS
    United Kingdom

    Site Not Available

  • University of California San Diego Health

    La Jolla, California 92037
    United States

    Site Not Available

  • Long Beach - VA

    Long Beach, California 90822
    United States

    Site Not Available

  • VA- Long Beach Healthcare

    Long Beach, California 90822
    United States

    Site Not Available

  • Keck Medicine of USC

    Los Angeles, California 90033
    United States

    Site Not Available

  • UCLA Medical Center

    Los Angeles, California 90095
    United States

    Site Not Available

  • Palo Alto - VA

    Palo Alto, California 94305
    United States

    Site Not Available

  • Stanford University

    Palo Alto, California 94305
    United States

    Site Not Available

  • VA - Palo Alto Healthcare

    Palo Alto, California 94305
    United States

    Site Not Available

  • Kaiser Permanente San Francisco

    San Francisco, California 94118
    United States

    Site Not Available

  • St. Joesph's Medical Center

    Stockton, California 95204
    United States

    Site Not Available

  • MedStar Health Research Institute

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • HCA Florida JFK Hospital

    Atlantis, Florida 33462
    United States

    Site Not Available

  • Cardiac & Vascular Institute

    Gainesville, Florida 32605
    United States

    Site Not Available

  • HCA Florida Largo Hospital

    Largo, Florida 33770
    United States

    Site Not Available

  • HCA Florida Northside Hospital

    Saint Petersburg, Florida 33709
    United States

    Site Not Available

  • Tallahassee Research Institute

    Tallahassee, Florida 32308
    United States

    Site Not Available

  • Archbold Hospital

    Thomasville, Georgia 31792
    United States

    Site Not Available

  • Carle Foundation Hospital

    Urbana, Illinois 61801
    United States

    Site Not Available

  • Ascension Via Christi St. Francis

    Wichita, Kansas 67214
    United States

    Site Not Available

  • Kansas Heart Hospital

    Wichita, Kansas 67226
    United States

    Site Not Available

  • St. Elizabeth Healthcare

    Edgewood, Kentucky 41017
    United States

    Site Not Available

  • Medstar Union Memorial Hospital

    Baltimore, Maryland 21218
    United States

    Site Not Available

  • TidalHealth, INC

    Salisbury, Maryland 21801
    United States

    Site Not Available

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Ascension St. John Hospital

    Detroit, Michigan 48236
    United States

    Site Not Available

  • William Beaumont Hospital

    Royal Oak, Michigan 48073
    United States

    Site Not Available

  • Metropolitan Heart Vascular Institute

    Coon Rapids, Minnesota 55433
    United States

    Site Not Available

  • Minneapolis Heart Institute Foundation

    Minneapolis, Minnesota 55407
    United States

    Site Not Available

  • Cardiac Associates Research

    Tupelo, Mississippi 38801
    United States

    Site Not Available

  • Mountainside Medical Center

    Montclair, New Jersey 07042
    United States

    Site Not Available

  • Morristown Medical Center

    Morristown, New Jersey 07960
    United States

    Site Not Available

  • The Valley Hospital

    Ridgewood, New Jersey 07450
    United States

    Site Not Available

  • New York Presbyterian Methodist Hospital

    Brooklyn, New York 11215
    United States

    Site Not Available

  • Columbia University Medical Center / New York Presbyterian Hospital

    New York, New York 10032
    United States

    Site Not Available

  • NYU Langone Health

    New York, New York 10016
    United States

    Site Not Available

  • New York Presbyterian / Weill Cornell Medical Center

    New York, New York 10065
    United States

    Site Not Available

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

    New York, New York 10075
    United States

    Site Not Available

  • St. Francis Hospital and Heart Center

    Roslyn, New York 11576
    United States

    Site Not Available

  • Ellis Hospital

    Schenectady, New York 12308
    United States

    Site Not Available

  • The Christ Hospital

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • Cleveland Clinic Foundation

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Mount Carmel Health System

    Columbus, Ohio 43219
    United States

    Site Not Available

  • University Hospitals Elyria Medical Center

    Elyria, Ohio 44035
    United States

    Site Not Available

  • Oregon Health and Science University

    Portland, Oregon 97239
    United States

    Site Not Available

  • Lehigh Valley Health

    Allentown, Pennsylvania 18103
    United States

    Site Not Available

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Baylor Scott & White The Heart Hospital - Plano

    Plano, Texas 75093
    United States

    Site Not Available

  • HCA Methodist Healthcare of San Antonio

    San Antonio, Texas 78249
    United States

    Site Not Available

  • Inova Fairfax Hospital

    Fairfax, Virginia 22031
    United States

    Site Not Available

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