To test whether FFRangio-guided treatment is non-inferior to conventional pressure wire-guided treatment in patients with coronary artery disease.
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
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
1,924
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.
Using an invasive pressure-wire to assess functional significance of coronary lesions either under hyperemic conditions (FFR) or utilizing Non-hyperemic pressure ratios (NHPR).
MACE
Rate of the composite of all-cause death, myocardial infarction (MI) or unplanned clinically-driven revascularization
Time frame: 1 year
All-Cause Mortality
Total rate of death from any cause
Time frame: 12 months
Myocardial Infarction
Total rate of myocardial infarction
Time frame: 12 months
Unplanned Revascularization
Total rate of unplanned clinically-driven revascularization
Time frame: 12 months
Stent thrombosis
Total rate of definite or probable stent thrombosis
Time frame: 12 months
Peri-Procedural Complications
Rate of peri-procedural complications defined as angiographic complications in the study vessel.
Time frame: 30 Days
Stroke
Rate of disabling stroke
Time frame: 30 Days
Bleeding
Rate of Major bleeding
Time frame: 30 Days
Kidney Injury
Rate of Acute kidney injury (AKI)
Time frame: 30 Days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University of California San Diego Health
La Jolla, California, United States
VA- Long Beach Healthcare
Long Beach, California, United States
Keck Medicine of USC
Los Angeles, California, United States
UCLA Medical Center
Los Angeles, California, United States
Stanford University
Palo Alto, California, United States
VA - Palo Alto Healthcare
Palo Alto, California, United States
Kaiser Permanente San Francisco
San Francisco, California, United States
St. Joesph's Medical Center
Stockton, California, United States
HCA Florida JFK Hospital
Atlantis, Florida, United States
Cardiac & Vascular Institute
Gainesville, Florida, United States
...and 49 more locations
Patient Reported Health Status - SAQ-7
Seattle Angina Questionnaire (SAQ-7)
Time frame: Baseline, Day 30 and 12 Months
Patient Reported Quality of Life - EQ-5D
EuroQol Group EQ-5D-5L
Time frame: Baseline, Day 30 and 12 Months
Procedure Time
Total time from arterial access to removal of last catheter in minutes
Time frame: 24 hours
Contrast Dose
Total amount of contrast used in ml
Time frame: 24 hours
Radiation Dose
Total amount of radiation in Gy
Time frame: 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).
Time frame: 24 hours
Cost-effectiveness
Cumulative healthcare cost in dollars for every major adverse event avoided
Time frame: 12 Months
FFRangio Usability
Ability to conduct the FFRangio assessment without any system malfunction
Time frame: 24 hours
Pressure Wire Usability
Ability to conduct the pressure wire based assessment without any system malfunction
Time frame: 24 hours