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.
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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.
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General Exclusion Criteria:
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Subject with ST-elevation (MI (STEMI) within 72 hours at time of study enrollment
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Prior coronary artery bypass graft (CABG) with patent grafts to the study vessel(s)
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Patients undergoing coronary physiologic assessment prior to possible CABG.
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The study vessel supplies a significant nonviable territory (e.g., prior transmural MI)
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Severe left sided valvular heart disease
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LVEF = 30%
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Women who are pregnant or breastfeeding
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Patients with life expectancy <1 year life as estimated by treating physician.
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Subjects enrolled in other ongoing clinical studies.
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non-registry clinical studies that would impact conduct or outcomes of this study (registries and long-term follow-up of other studies are allowed)
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10. Subjects who have undergone angiographic or wire-based coronary physiological assessment for 1 or more potential study lesions within 30 days of enrollment
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