Advancing Cath Lab Results With FFRangio Coronary Physiology Assessment

About

Brief Summary

To test whether FFRangio-guided treatment is non-inferior to conventional pressure wire-guided treatment in patients with coronary artery disease.

Primary Purpose

Diagnostic

Study Type

Interventional

Phase

Phase 4

Gender

All

Healthy Volunteers

No

Minimum Age

18 Years

Maximum Age

N/A

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.

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.