Clinical trial NCT05893498: Advancing Cath Lab Results With FFRangio Coronary Physiology Assessment
Official title: Advancing Cath Lab Results With FFRangio Coronary Physiology Assessment
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Percutaneous Coronary Intervention
Keywords: PCI
Coronary Artery Disease
FFRangio
Pressure Wire-Guided
Lead sponsor: CathWorks Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Cardiovascular Research Foundation, New York
First posted: 2023-06-08
Enrollment: 1924
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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 criteria: 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.

Primary outcomes:
measure: MACE
timeFrame: 1 year
Secondary outcomes:
measure: All-Cause Mortality
timeFrame: 12 months
measure: Myocardial Infarction
timeFrame: 12 months
measure: Unplanned Revascularization
timeFrame: 12 months
measure: Stent thrombosis
timeFrame: 12 months
measure: Peri-Procedural Complications
timeFrame: 30 Days
measure: Stroke
timeFrame: 30 Days
measure: Bleeding
timeFrame: 30 Days
measure: Kidney Injury
timeFrame: 30 Days
measure: Patient Reported Health Status - SAQ-7
timeFrame: Baseline, Day 30 and 12 Months
measure: Patient Reported Quality of Life - EQ-5D
timeFrame: Baseline, Day 30 and 12 Months
measure: Procedure Time
timeFrame: 24 hours
measure: Contrast Dose
timeFrame: 24 hours
measure: Radiation Dose
timeFrame: 24 hours
measure: Resource utilization
timeFrame: 24 hours
measure: Cost-effectiveness
timeFrame: 12 Months
measure: FFRangio Usability
timeFrame: 24 hours
measure: Pressure Wire Usability
timeFrame: 24 hours
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California San Diego Health
state: California
city: Long Beach
country: United States
facility: VA- Long Beach Healthcare
state: California
city: Los Angeles
country: United States
facility: Keck Medicine of USC
state: California
city: Los Angeles
country: United States
facility: UCLA Medical Center
state: California
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: Palo Alto
country: United States
facility: VA - Palo Alto Healthcare
state: California
city: San Francisco
country: United States
facility: Kaiser Permanente San Francisco
state: California
city: Stockton
country: United States
facility: St. Joesph's Medical Center
state: California
city: Washington
country: United States
facility: MedStar Health Research Institute
state: District of Columbia
city: Atlantis
country: United States
facility: HCA Florida JFK Hospital
state: Florida
city: Gainesville
country: United States
facility: Cardiac & Vascular Institute
state: Florida
city: Largo
country: United States
facility: HCA Florida Largo Hospital
state: Florida
city: Saint Petersburg
country: United States
facility: HCA Florida Northside Hospital
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Research Institute
state: Florida
city: Thomasville
country: United States
facility: Archbold Hospital
state: Georgia
city: Urbana
country: United States
facility: Carle Foundation Hospital
state: Illinois
city: Wichita
country: United States
facility: Ascension Via Christi St. Francis
state: Kansas
city: Wichita
country: United States
facility: Kansas Heart Hospital
state: Kansas
city: Edgewood
country: United States
facility: St. Elizabeth Healthcare
state: Kentucky
city: Baltimore
country: United States
facility: Medstar Union Memorial Hospital
state: Maryland
city: Salisbury
country: United States
facility: TidalHealth, INC
state: Maryland
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Ascension St. John Hospital
state: Michigan
city: Coon Rapids
country: United States
facility: Metropolitan Heart Vascular Institute
state: Minnesota
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute Foundation
state: Minnesota
city: Tupelo
country: United States
facility: Cardiac Associates Research
state: Mississippi
city: Montclair
country: United States
facility: Mountainside Medical Center
state: New Jersey
city: Morristown
country: United States
facility: Morristown Medical Center
state: New Jersey
city: Ridgewood
country: United States
facility: The Valley Hospital
state: New Jersey
city: Brooklyn
country: United States
facility: New York Presbyterian Methodist Hospital
state: New York
city: New York
country: United States
facility: NYU Langone Health
state: New York
city: New York
country: United States
facility: Columbia University Medical Center / New York Presbyterian Hospital
state: New York
city: New York
country: United States
facility: New York Presbyterian / Weill Cornell Medical Center
state: New York
city: New York
country: United States
facility: Northwell Health (Lenox Hill, North Shore, South Shore, Huntington, Staten Island))
state: New York
city: Roslyn
country: United States
facility: St. Francis Hospital and Heart Center
state: New York
city: Schenectady
country: United States
facility: Ellis Hospital
state: New York
city: Cincinnati
country: United States
facility: The Christ Hospital
state: Ohio
city: Columbus
country: United States
facility: Mount Carmel Health System
state: Ohio
city: Allentown
country: United States
facility: Lehigh Valley Health
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Plano
country: United States
facility: Baylor Scott & White The Heart Hospital - Plano
state: Texas
city: San Antonio
country: United States
facility: HCA Methodist Healthcare of San Antonio
state: Texas
city: Fairfax
country: United States
facility: Inova Fairfax Hospital
state: Virginia
city: Petah-Tikva
country: Israel
facility: Rabin Medical Centre
city: Gifu
country: Japan
facility: Gifu Heart Center
city: Kobe City
country: Japan
facility: Kobe University
city: Osaka
country: Japan
facility: Mie University Hospital
city: Tokyo
country: Japan
facility: Sakakibara Heart Institute
city: Geneva
country: Switzerland
facility: Hopitaux Universitaires Geneve (HUG)
city: Lausanne
country: Switzerland
facility: centre hospitalier universitaire vaudois (CHUV)
city: London
country: United Kingdom
facility: Imperial College Healthcare
Study officials:
affiliation: NewYork-Presbyterian/Columbia University Irving Medical Center
name: Ajay J Kirtane, MD, SM
role: STUDY_CHAIR
affiliation: Stanford University
name: William F Fearon, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Francis Hospital & Heart Center
name: Allen Jeremias, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: NewYork-Presbyterian/Columbia University Irving Medical Center
name: Martin B Leon, MD
role: STUDY_CHAIR
References: