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

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ClinicalTrials.gov Identifier: NCT05893498

Recruitment Status : Recruiting

First Posted : June 8, 2023

Last Update Posted : January 17, 2024

See Contacts and Locations

View this study on the modernized ClinicalTrials.gov

Sponsor:

Collaborator:

Cardiovascular Research Foundation, New York

Information provided by (Responsible Party):

CathWorks Ltd.

Tracking Information

First Submitted Date ^ICMJE

April 25, 2023

First Posted Date ^ICMJE

June 8, 2023

Last Update Posted Date

January 17, 2024

Actual Study Start Date ^ICMJE

June 21, 2023

Estimated Primary Completion Date

December 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

MACE [ Time Frame: 1 year ]

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title ^ICMJE

Advancing Cath Lab Results With FFRangio Coronary Physiology Assessment

Official Title ^ICMJE

Advancing Cath Lab Results With FFRangio Coronary Physiology Assessment

Brief Summary

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

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 ^ICMJE

Interventional

Study Phase ^ICMJE

Not Applicable

Study Design ^ICMJE

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

Condition ^ICMJE

Percutaneous Coronary Intervention

Intervention ^ICMJE

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.
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

Study Arms ^ICMJE

Experimental: FFRangio
FFRangio guided revascularization

Intervention: Device: FFRangio
Active Comparator: Pressure wire
Pressure wire-based guided revascularization (FFR or NHPR)

Intervention: Device: FFR or NHPR

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

1924

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date ^ICMJE

December 2024

Estimated Primary Completion Date

December 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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:

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 prior to possible CABG.
The study vessel supplies a significant nonviable territory (e.g., prior transmural MI)
Severe left sided valvular heart disease
LVEF ≤ 30%
Women who are pregnant or breastfeeding
Patients with life expectancy <1 year life as estimated by treating physician.
Subjects enrolled in other ongoing clinical studies.

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers ^ICMJE

Contacts ^ICMJE

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

Listed Location Countries ^ICMJE

Israel, United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT05893498

Other Study ID Numbers ^ICMJE

CathWorks CWX-08

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

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

IPD Sharing Statement ^ICMJE

Plan to Share IPD:

Current Responsible Party

CathWorks Ltd.

Original Responsible Party

Same as current

Current Study Sponsor ^ICMJE

CathWorks Ltd.

Original Study Sponsor ^ICMJE

Same as current

Collaborators ^ICMJE

Cardiovascular Research Foundation, New York

Investigators ^ICMJE

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

PRS Account

CathWorks Ltd.

Verification Date

January 2024

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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