NCT05893498Active, not recruitingNot Applicable
Advancing Cath Lab Results With FFRangio Coronary Physiology Assessment
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- CathWorks Ltd.
- Enrollment
- 1,924
- Locations
- 59
- Primary Endpoint
- MACE
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •1. Adult patients (≥18 years of age) with one or more study lesion(s) (diameter stenosis 50-90%) deemed appropriate for both pressure-wire and FFRangio physiologic assessment.
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 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.
- •Angiographic Exclusion Criteria:
- •Coronary angiogram is not acquired per instructions as defined in the Study Protocol
- •Sthe study lesion is the clear culprit for a NSTEACS
- •Angiographic evidence of a procedural complication (e.g., acute stent thrombosis, flow-limiting dissection, perforation, slow/no reflow, or other) prior to randomization
- •Thrombolysis in myocardial infarction (TIMI) Grade 2 flow or lower in any study vessel at time of enrollment
- •The study vessel is in a left coronary vessel with separate left anterior descending and left circumflex ostia arising from the aorta
- •The study lesion involves the left main coronary artery (stenosis ≥ 50%)
- •The study lesion is in an ectatic or aneurysmal coronary segment (defined as lumen diameter 1.5x diameter or the reference vessel)
Arms & Interventions
FFRangio
Experimental
FFRangio guided revascularization
Intervention: FFRangio (Device)
Pressure wire
Active Comparator
Pressure wire-based guided revascularization (FFR or NHPR)
Intervention: FFR or NHPR (Device)
Outcomes
Primary Outcomes
MACE
Time Frame: 1 year
Rate of the composite of all-cause death, myocardial infarction (MI) or unplanned clinically-driven revascularization
Secondary Outcomes
- Patient Reported Quality of Life - EQ-5D(Baseline, Day 30 and 12 Months)
- Procedure Time(24 hours)
- Stroke(30 Days)
- FFRangio Usability(24 hours)
- All-Cause Mortality(12 months)
- Unplanned Revascularization(12 months)
- Peri-Procedural Complications(30 Days)
- Bleeding(30 Days)
- Patient Reported Health Status - SAQ-7(Baseline, Day 30 and 12 Months)
- Contrast Dose(24 hours)
- Cost-effectiveness(12 Months)
- Myocardial Infarction(12 months)
- Kidney Injury(30 Days)
- Radiation Dose(24 hours)
- Resource utilization(24 hours)
- Stent thrombosis(12 months)
- Pressure Wire Usability(24 hours)
Investigators
Study Sites (59)
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