Advancing Cath Lab Results With FFRangio Coronary Physiology Assessment

Purpose

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

Condition

  • Percutaneous Coronary Intervention

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  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

Exclusion Criteria

  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 where one possible outcome is referral for CABG 4. The study vessel supplies a significant nonviable territory (e.g., prior transmural MI) 5. Severe left sided valvular heart disease 6. Most recent documented LVEF ≤30% 7. Women who are pregnant or breastfeeding (women of childbearing potential are required to have negative pregnancy test within 1 week of index procedure) 8. Patients with life expectancy <1 year life as estimated by treating physician. 9. 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) 10. Subjects who have undergone angiographic or wire-based coronary physiological assessment for 1 or more potential study lesions within 30 days of enrollment.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Diagnostic
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
FFRangio 		FFRangio guided revascularization
  • Device: FFRangio
    A 3D image-base software device (CathWorks, Ltd, Kfar Saba, Israel) using three (3) angiographic views to provide a quantitative analysis of the functional significance of coronary lesions.
Active Comparator
Pressure wire 		Pressure wire-based guided revascularization (FFR or NHPR)
  • Device: FFR or NHPR
    Using an invasive pressure-wire to assess functional significance of coronary lesions either under hyperemic conditions (FFR) or utilizing Non-hyperemic pressure ratios (NHPR).
    Other names:
    • FFR, iFR RFR, dPR, Pd/Pa

Recruiting Locations

Medstar Union Memorial Hospital
Baltimore, Maryland 21218

MedStar Health Research Institute
Washington, District of Columbia 20010

More Details

Status
Recruiting
Sponsor
CathWorks Ltd.

Study Contact

Alex Froimovich, MD
949-966-0291
alex.froimovich@cath.works

Detailed Description

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.