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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

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

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
Contact
Ladda Douangvila-Chhan
Location
  • UCLA Westwood
For Providers
NCT No.
NCT05893498
For detailed technical eligibility, visit ClinicalTrials.gov.