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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05893498
Recruitment Status : Recruiting
First Posted : June 8, 2023
Last Update Posted : November 22, 2023
Sponsor:
Collaborator:
Cardiovascular Research Foundation, New York
Information provided by (Responsible Party):
CathWorks Ltd.

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

Condition or disease Intervention/treatment Phase
Percutaneous Coronary Intervention Device: FFRangio Device: FFR or NHPR Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1924 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Advancing Cath Lab Results With FFRangio Coronary Physiology Assessment
Actual Study Start Date : June 21, 2023
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024
Arms and Interventions
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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 Name: FFR, iFR RFR, dPR, Pd/Pa


Outcome Measures
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Primary Outcome Measures :
  1. MACE [ Time Frame: 1 year ]
    Rate of the composite of all-cause death, myocardial infarction (MI) or unplanned clinically-driven revascularization


Secondary Outcome Measures :
  1. All-Cause Mortality [ Time Frame: 12 months ]
    Total rate of death from any cause

  2. Myocardial Infarction [ Time Frame: 12 months ]
    Total rate of myocardial infarction

  3. Unplanned Revascularization [ Time Frame: 12 months ]
    Total rate of unplanned clinically-driven revascularization

  4. Stent thrombosis [ Time Frame: 12 months ]
    Total rate of definite or probable stent thrombosis

  5. Peri-Procedural Complications [ Time Frame: 30 Days ]
    Rate of peri-procedural complications defined as angiographic complications in the study vessel.

  6. Stroke [ Time Frame: 30 Days ]
    Rate of disabling stroke

  7. Bleeding [ Time Frame: 30 Days ]
    Rate of Major bleeding

  8. Kidney Injury [ Time Frame: 30 Days ]
    Rate of Acute kidney injury (AKI)

  9. Patient Reported Health Status - SAQ-7 [ Time Frame: Baseline, Day 30 and 12 Months ]
    Seattle Angina Questionnaire (SAQ-7)

  10. Patient Reported Quality of Life - EQ-5D [ Time Frame: Baseline, Day 30 and 12 Months ]
    EuroQol Group EQ-5D-5L

  11. Procedure Time [ Time Frame: 24 hours ]
    Total time from arterial access to removal of last catheter in minutes

  12. Contrast Dose [ Time Frame: 24 hours ]
    Total amount of contrast used in ml

  13. Radiation Dose [ Time Frame: 24 hours ]
    Total amount of radiation in Gy

  14. Resource utilization [ Time Frame: 24 hours ]
    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).

  15. Cost-effectiveness [ Time Frame: 12 Months ]
    Cumulative healthcare cost in dollars for every major adverse event avoided

  16. FFRangio Usability [ Time Frame: 24 hours ]
    Ability to conduct the FFRangio assessment without any system malfunction

  17. Pressure Wire Usability [ Time Frame: 24 hours ]
    Ability to conduct the pressure wire based assessment without any system malfunction


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

1. Adult patient ( ≥18 years old) presenting with CCS or NSTEACS with one or more study lesion(s) deemed appropriate (diameter stenosis 50-90%) 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 prior to possible CABG.
  4. The study vessel supplies a significant nonviable territory (e.g., prior transmural MI)
  5. Severe left sided valvular heart disease
  6. LVEF ≤ 30%
  7. Women who are pregnant or breastfeeding
  8. Patients with life expectancy <1 year life as estimated by treating physician.
  9. Subjects enrolled in other ongoing clinical studies.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05893498


Contacts
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Contact: Alex Froimovich, MD 949-966-0291 alex.froimovich@cath.works
Contact: Chi Chau chi.chau@cath.works

Locations
Show Show 18 study locations
Sponsors and Collaborators
CathWorks Ltd.
Cardiovascular Research Foundation, New York
Investigators
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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
More Information
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Responsible Party: CathWorks Ltd.
ClinicalTrials.gov Identifier: NCT05893498    
Other Study ID Numbers: CathWorks CWX-08
First Posted: June 8, 2023    Key Record Dates
Last Update Posted: November 22, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by CathWorks Ltd.:
PCI
Coronary Artery Disease
FFRangio
Pressure Wire-Guided