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Percutaneous Coronary InterventionALL-RISENCT05893498

Advancing Cath Lab Results With FFRangio Coronary Physiology Assessment

A study testing FFRangio and FFR or NHPR in people with Percutaneous Coronary Intervention, run by CathWorks Ltd. at 59 sites in 5 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Percutaneous Coronary Intervention
What is being tested?
FFRangio and FFR or NHPR
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,924 participants
Where
59 sitesin 5 countries
Study dates
21 Jun 2023to May 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • 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)
Show all 20Show fewer
  • 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.
  • Angiographic Exclusion Criteria:
  • 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
  • The study lesion involves the left main coronary artery (stenosis ≥ 50%)
  • The study lesion is in an ectatic or aneurysmal coronary segment (defined as lumen diameter 1.5x diameter or the reference vessel)

Who cannot join

None listed.

Trial locations and contacts

59 sites in 5 countries.

59 sites in 5 countries

United States43 sites

  • Lehigh Valley Health

    Allentown, Pennsylvania, 18103

  • HCA Florida JFK Hospital

    Atlantis, Florida, 33462

  • Medstar Union Memorial Hospital

    Baltimore, Maryland, 21218

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • New York Presbyterian Methodist Hospital

    Brooklyn, New York, 11215

  • The Christ Hospital

    Cincinnati, Ohio, 45219

  • Mount Carmel Health System

    Columbus, Ohio, 43219

  • Metropolitan Heart Vascular Institute

    Coon Rapids, Minnesota, 55433

  • Ascension St. John Hospital

    Detroit, Michigan, 48236

  • St. Elizabeth Healthcare

    Edgewood, Kentucky, 41017

  • Inova Fairfax Hospital

    Fairfax, Virginia, 22031

  • Cardiac & Vascular Institute

    Gainesville, Florida, 32605

  • University of California San Diego Health

    La Jolla, California, 92037

  • VA- Long Beach Healthcare

    Long Beach, California, 90822

  • Keck Medicine of USC

    Los Angeles, California, 90033

  • UCLA Medical Center

    Los Angeles, California, 90095

  • University of Miami

    Miami, Florida, 33136

  • Minneapolis Heart Institute Foundation

    Minneapolis, Minnesota, 55407

  • Mountainside Medical Center

    Montclair, New Jersey, 07042

  • Morristown Medical Center

    Morristown, New Jersey, 07960

  • NYU Langone Health

    New York, New York, 10016

  • Columbia University Medical Center / New York Presbyterian Hospital

    New York, New York, 10032

  • New York Presbyterian / Weill Cornell Medical Center

    New York, New York, 10065

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

    New York, New York, 10075

  • Stanford University

    Palo Alto, California, 94305

  • VA - Palo Alto Healthcare

    Palo Alto, California, 94305

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Baylor Scott & White The Heart Hospital - Plano

    Plano, Texas, 75093

  • The Valley Hospital

    Ridgewood, New Jersey, 07450

  • St. Francis Hospital and Heart Center

    Roslyn, New York, 11576

  • TidalHealth, INC

    Salisbury, Maryland, 21801

  • HCA Methodist Healthcare of San Antonio

    San Antonio, Texas, 78249

  • Kaiser Permanente San Francisco

    San Francisco, California, 94118

  • Ellis Hospital

    Schenectady, New York, 12308

  • HCA Florida Northside Hospital

    St. Petersburg, Florida, 33709

  • St. Joesph's Medical Center

    Stockton, California, 95204

  • Tallahassee Research Institute

    Tallahassee, Florida, 32308

  • University of South Florida

    Tampa, Florida, 33606

  • Archbold Hospital

    Thomasville, Georgia, 31792

  • Cardiac Associates Research

    Tupelo, Mississippi, 38801

  • Carle Foundation Hospital

    Urbana, Illinois, 61801

  • Ascension Via Christi St. Francis

    Wichita, Kansas, 67214

  • Kansas Heart Hospital

    Wichita, Kansas, 67226

Other trials in United States

Japan8 sites

  • Fukuyama Cardiovascular Hospital

    Fukuyama

  • Gifu Heart Center

    Gifu

  • Ichinomiyanishi Hospital

    Ichinomiya

  • Kobe University

    Kobe

  • Chibanishi General Hospital

    Matsudo

  • Mie University Hospital

    Osaka

  • NTT Medical Center Tokyo

    Tokyo

  • Sakakibara Heart Institute

    Tokyo

Other trials in Japan

Switzerland3 sites

  • Hopitaux Universitaires Geneve (HUG)

    Geneva

  • centre hospitalier universitaire vaudois (CHUV)

    Lausanne, CH-1011

  • Hôpital Cantonal de Fribourg (HFR)

    Villars-sur-Glâne

Other trials in Switzerland

United Kingdom3 sites

  • Basildon University Hospital

    Basildon

  • Imperial College Healthcare

    London, W12 0HS

  • Musgrove Park Hospital

    Taunton

Other trials in United Kingdom

Israel2 sites

  • Golda HaSharon Hospital

    Petah Tikva, 49372

  • Rabin Medical Centre

    Petah Tikva, 4941492

Other trials in Israel

About this study

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

Read the 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.

Being tested
FFRangio, FFR or NHPR
Keywords
PCI, Coronary Artery Disease, FFRangio, Pressure Wire-Guided
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FFRangioDevice

    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 NHPRDevice

    Also called FFR, iFR RFR, dPR, Pd/Pa

    Using an invasive pressure-wire to assess functional significance of coronary lesions either under hyperemic conditions (FFR) or utilizing Non-hyperemic pressure ratios (NHPR).

Study groups in NCT05893498
Study groupRoleWhat they receive
FFRangioExperimentalFFRangio guided revascularization
Receives: Device: FFRangio
Pressure wireActive comparatorPressure wire-based guided revascularization (FFR or NHPR)
Receives: Device: FFR or NHPR

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. MACE

    Rate of the composite of all-cause death, myocardial infarction (MI) or unplanned clinically-driven revascularization

    Measured: 1 year

Secondary outcomes (17)

  1. All-Cause Mortality

    Total rate of death from any cause

    Measured: 12 months

  2. Myocardial Infarction

    Total rate of myocardial infarction

    Measured: 12 months

  3. Unplanned Revascularization

    Total rate of unplanned clinically-driven revascularization

    Measured: 12 months

  4. Stent thrombosis

    Total rate of definite or probable stent thrombosis

    Measured: 12 months

  5. Peri-Procedural Complications

    Rate of peri-procedural complications defined as angiographic complications in the study vessel.

    Measured: 30 Days

  6. Stroke

    Rate of disabling stroke

    Measured: 30 Days

  7. Bleeding

    Rate of Major bleeding

    Measured: 30 Days

  8. Kidney Injury

    Rate of Acute kidney injury (AKI)

    Measured: 30 Days

  9. Patient Reported Health Status - SAQ-7

    Seattle Angina Questionnaire (SAQ-7)

    Measured: Baseline, Day 30 and 12 Months

  10. Patient Reported Quality of Life - EQ-5D

    EuroQol Group EQ-5D-5L

    Measured: Baseline, Day 30 and 12 Months

  11. Procedure Time

    Total time from arterial access to removal of last catheter in minutes

    Measured: 24 hours

  12. Contrast Dose

    Total amount of contrast used in ml

    Measured: 24 hours

  13. Radiation Dose

    Total amount of radiation in Gy

    Measured: 24 hours

  14. 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).

    Measured: 24 hours

  15. Cost-effectiveness

    Cumulative healthcare cost in dollars for every major adverse event avoided

    Measured: 12 Months

  16. FFRangio Usability

    Ability to conduct the FFRangio assessment without any system malfunction

    Measured: 24 hours

  17. Pressure Wire Usability

    Ability to conduct the pressure wire based assessment without any system malfunction

    Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2023
  2. Study start21 Jun 2023
  3. Primary completionMay 2026 (estimated)
  4. Study completionMay 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,924 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05893498
Sponsor's protocol ID
CathWorks CWX-08
Acronym
ALL-RISE
Status last verified
Mar 2026
First submitted
25 Apr 2023
Last updated
10 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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 Jul 2;395(1):9-19. doi: 10.1056/NEJMoa2600949. Epub 2026 Mar 29.

    PubMed 41910384

  • 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.

    PubMed 40828315

Questions about this trial

What is this clinical trial studying?

A study testing FFRangio and FFR or NHPR in people with Percutaneous Coronary Intervention, run by CathWorks Ltd. at 59 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 59 sites in United States, Japan, Switzerland, United Kingdom, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MACE (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05893498, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.

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