Advancing Cath Lab Results With FFRangio Coronary Physiology Assessment

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.

Inclusion criteria

• 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.

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 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)