Advancing Cath Lab Results With FFRangio Coronary Physiology Assessment
- Conditions
- Percutaneous Coronary Intervention
- Registration Number
- NCT05893498
- Lead Sponsor
- CathWorks Ltd.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1924
- 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
- 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)
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method MACE 1 year Rate of the composite of all-cause death, myocardial infarction (MI) or unplanned clinically-driven revascularization
- Secondary Outcome Measures
Name Time Method Patient Reported Quality of Life - EQ-5D Baseline, Day 30 and 12 Months EuroQol Group EQ-5D-5L
FFRangio Usability 24 hours Ability to conduct the FFRangio assessment without any system malfunction
Cost-effectiveness 12 Months Cumulative healthcare cost in dollars for every major adverse event avoided
Myocardial Infarction 12 months Total rate of myocardial infarction
Kidney Injury 30 Days Rate of Acute kidney injury (AKI)
Radiation Dose 24 hours Total amount of radiation in Gy
Resource utilization 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).
Stent thrombosis 12 months Total rate of definite or probable stent thrombosis
Pressure Wire Usability 24 hours Ability to conduct the pressure wire based assessment without any system malfunction
Stroke 30 Days Rate of disabling stroke
Procedure Time 24 hours Total time from arterial access to removal of last catheter in minutes
All-Cause Mortality 12 months Total rate of death from any cause
Unplanned Revascularization 12 months Total rate of unplanned clinically-driven revascularization
Peri-Procedural Complications 30 Days Rate of peri-procedural complications defined as angiographic complications in the study vessel.
Bleeding 30 Days Rate of Major bleeding
Patient Reported Health Status - SAQ-7 Baseline, Day 30 and 12 Months Seattle Angina Questionnaire (SAQ-7)
Contrast Dose 24 hours Total amount of contrast used in ml
Trial Locations
- Locations (51)
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
MedStar Health Research Institute
🇺🇸Washington, District of Columbia, United States
HCA Florida JFK Hospital
🇺🇸Atlantis, Florida, United States
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