Advancing Cath Lab Results With FFRangio Coronary Physiology Assessment

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

Detailed Description
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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.

Official Title
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Advancing Cath Lab Results With FFRangio Coronary Physiology Assessment

Conditions
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Percutaneous Coronary Intervention

Intervention / Treatment
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* Device: FFRangio
* Device: FFR or NHPR


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FFRangio<br>FFRangio guided revascularization | Device: FFRangio<br>* 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.<br>|
| Active Comparator: Pressure wire<br>Pressure wire-based guided revascularization (FFR or NHPR) | Device: FFR or NHPR<br>* Using an invasive pressure-wire to assess functional significance of coronary lesions either under hyperemic conditions (FFR) or utilizing Non-hyperemic pressure ratios (NHPR).<br>* Other names: FFR, iFR RFR, dPR, Pd/Pa;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PCI, Coronary Artery Disease, FFRangio, Pressure Wire-Guided