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Advancing Cath Lab Results With FFRangio Coronary Physiology Assessment | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGNA

Advancing Cath Lab Results With FFRangio Coronary Physiology Assessment

NCT05893498•CathWorks Ltd.

Summary

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

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1\. Adult patients (≥18 years of age) with one or more study lesion(s) (diameter stenosis 50-90%) deemed appropriate for both pressure-wire and FFRangio physiologic assessment.

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.
+7 more criteria

Locations (59)

University of California San Diego Health

La Jolla, California, United States

VA- Long Beach Healthcare

Long Beach, California, United States

Keck Medicine of USC

Los Angeles, California, United States

UCLA Medical Center

Los Angeles, California, United States

Stanford University

Palo Alto, California, United States

VA - Palo Alto Healthcare

Palo Alto, California, United States

Kaiser Permanente San Francisco

San Francisco, California, United States

St. Joesph's Medical Center

Stockton, California, United States

HCA Florida JFK Hospital

Atlantis, Florida, United States

Cardiac & Vascular Institute

Gainesville, Florida, United States

Key Dates

Start Date

June 21, 2023

Primary Completion Date

May 1, 2026

Completion Date

May 1, 2026

Last Updated

March 10, 2026

Enrollment

1,924

ESTIMATED participants

Conditions

Percutaneous Coronary Intervention

Interventions

FFRangio

DEVICE

FFR or NHPR

DEVICE

ELEVATE High-Risk PCI Pivotal Study

NCT07001332

High-Risk Percutaneous Coronary Intervention (High-risk PCI)

View study

RECRUITINGPHASE4

Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention

NCT06909565

Percutaneous Coronary InterventionPeripheral Endovascular Intervention

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 10, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Advancing Cath Lab Results With FFRangio Coronary Physiology Assessment

Inclusion Criteria

Exclusion Criteria

ELEVATE High-Risk PCI Pivotal Study

Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention

Prasugrel Monotherapy Reduced Dose in Acute and Chronic Coronary Syndrome Patients After Percutaneous Coronary Intervention (PROMOTE)

Drug-Coated Balloon Primary PCI in ST-Segment Elevation Myocardial Infarction

Aerobic Exercise-induced Effect on Endothelial Function in Patients With Ischaemic Heart Disease

Remote Ischemic Preconditioning for Renal and Cardiac Protection in Congestive Heart Failure (RICH) Trial