Advancing Cath Lab Results With FFRangio Coronary Physiology Assessment

a study on Percutaneous Coronary Intervention

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSD
Dates
study started
completion around

Description

Summary

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

Details

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.

Keywords

Percutaneous Coronary Intervention, PCI, Coronary Artery Disease, FFRangio, Pressure Wire-Guided, FFR or NHPR, Pressure wire

Eligibility

You can join if…

Open to people ages 18 years and up

  1. 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

You CAN'T join if...

  1. Subject with ST-elevation (MI (STEMI) within 72 hours at time of study enrollment
  2. Prior coronary artery bypass graft (CABG) with patent grafts to the study vessel(s)
  3. Patients undergoing coronary physiologic assessment prior to possible CABG.
  4. The study vessel supplies a significant nonviable territory (e.g., prior transmural MI)
  5. Severe left sided valvular heart disease
  6. LVEF ≤ 30%
  7. Women who are pregnant or breastfeeding
  8. Patients with life expectancy <1 year life as estimated by treating physician.
  9. Subjects enrolled in other ongoing clinical studies.

Locations

  • University of California San Diego Health accepting new patients
    La Jolla California 92037 United States
  • Keck Medicine of USC accepting new patients
    Los Angeles California 90033 United States
  • VA- Long Beach Healthcare not yet accepting patients
    Long Beach California 90822 United States
  • Stanford University accepting new patients
    Palo Alto California 94305 United States
  • VA - Palo Alto Healthcare accepting new patients
    Palo Alto California 94305 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
CathWorks Ltd.
ID
NCT05893498
Study Type
Interventional
Participants
Expecting 1924 study participants
Last Updated