Advancing Cath Lab Results With FFRangio Coronary Physiology Assessment

Percutaneous Coronary Intervention Clinical Trial

— ALL-RISE  

Official title:

Advancing Cath Lab Results With FFRangio Coronary Physiology Assessment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05893498
• Other study ID #: CathWorks CWX-08
• Status: Recruiting
• Phase: N/A
• Start date: June 21, 2023
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: CathWorks Ltd.
• Contact: Alex Froimovich, MD
• Phone: 949-966-0291
• Email: alex.froimovich[@]cath.works
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1924
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 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.

Related Conditions & MeSH terms

• Percutaneous Coronary Intervention

Intervention

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.
• 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).

Locations

Country	Name	City	State
Israel	Rabin Medical Centre	Petah-Tikva
United States	Lehigh Valley Health	Allentown	Pennsylvania
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	The Christ Hospital	Cincinnati	Ohio
United States	Ascension St. John Hospital	Detroit	Michigan
United States	University Hospitals Elyria Medical Center	Elyria	Ohio
United States	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	Columbia University Medical Center / New York Presbyterian Hospital	New York	New York
United States	New York Presbyterian / Weill Cornell Medical Center	New York	New York
United States	NYU Langone Health	New York	New York
United States	Stanford University	Palo Alto	California
United States	VA - Palo Alto Healthcare	Palo Alto	California
United States	Baylor Scott & White The Heart Hospital - Plano	Plano	Texas
United States	Oregon Health and Science University	Portland	Oregon
United States	St. Francis Hospital and Heart Center	Roslyn	New York
United States	Carle Foundation Hospital	Urbana	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
CathWorks Ltd.	Cardiovascular Research Foundation, New York

Countries where clinical trial is conducted

United States,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MACE	Rate of the composite of all-cause death, myocardial infarction (MI) or unplanned clinically-driven revascularization	1 year
Secondary	All-Cause Mortality	Total rate of death from any cause	12 months
Secondary	Myocardial Infarction	Total rate of myocardial infarction	12 months
Secondary	Unplanned Revascularization	Total rate of unplanned clinically-driven revascularization	12 months
Secondary	Stent thrombosis	Total rate of definite or probable stent thrombosis	12 months
Secondary	Peri-Procedural Complications	Rate of peri-procedural complications defined as angiographic complications in the study vessel.	30 Days
Secondary	Stroke	Rate of disabling stroke	30 Days
Secondary	Bleeding	Rate of Major bleeding	30 Days
Secondary	Kidney Injury	Rate of Acute kidney injury (AKI)	30 Days
Secondary	Patient Reported Health Status - SAQ-7	Seattle Angina Questionnaire (SAQ-7)	Baseline, Day 30 and 12 Months
Secondary	Patient Reported Quality of Life - EQ-5D	EuroQol Group EQ-5D-5L	Baseline, Day 30 and 12 Months
Secondary	Procedure Time	Total time from arterial access to removal of last catheter in minutes	24 hours
Secondary	Contrast Dose	Total amount of contrast used in ml	24 hours
Secondary	Radiation Dose	Total amount of radiation in Gy	24 hours
Secondary	Resource utilization	Hospital costs will be assessed for all patients based on procedural and index hospitalization resource utilization and standard US costs for each resource (including procedural time).	24 hours
Secondary	Cost-effectiveness	Cumulative healthcare cost in dollars for every major adverse event avoided	12 Months
Secondary	FFRangio Usability	Ability to conduct the FFRangio assessment without any system malfunction	24 hours
Secondary	Pressure Wire Usability	Ability to conduct the pressure wire based assessment without any system malfunction	24 hours