Open
Actively Recruiting
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
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
Inclusion Criteria:
- 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 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 prior to possible CABG.
- The study vessel supplies a significant nonviable territory (e.g., prior transmural MI)
- Severe left sided valvular heart disease
- LVEF ≤ 30%
- Women who are pregnant or breastfeeding
- Patients with life expectancy <1 year life as estimated by treating physician.
- Subjects enrolled in other ongoing clinical studies.
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Study Stats
Protocol No.
24-5165
Category
Heart/Cardiovascular Diseases
Principal Investigator
Contact
Location
- UCLA Westwood