Percutaneous Coronary Intervention
Conditions
Keywords
PCI, Coronary Artery Disease, FFRangio, Pressure Wire-Guided
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.
Interventions
DEVICEFFRangio
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.
DEVICEFFR 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).
Sponsors
CathWorks Ltd.
Cardiovascular Research Foundation, New York
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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. 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. Angiographic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MACE | 1 year | Rate of the composite of all-cause death, myocardial infarction (MI) or unplanned clinically-driven revascularization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All-Cause Mortality | 12 months | Total rate of death from any cause |
| Myocardial Infarction | 12 months | Total rate of myocardial infarction |
| Unplanned Revascularization | 12 months | Total rate of unplanned clinically-driven revascularization |
| Stent thrombosis | 12 months | Total rate of definite or probable stent thrombosis |
| Peri-Procedural Complications | 30 Days | Rate of peri-procedural complications defined as angiographic complications in the study vessel. |
| Stroke | 30 Days | Rate of disabling stroke |
| Bleeding | 30 Days | Rate of Major bleeding |
| Kidney Injury | 30 Days | Rate of Acute kidney injury (AKI) |
| Patient Reported Health Status - SAQ-7 | Baseline, Day 30 and 12 Months | Seattle Angina Questionnaire (SAQ-7) |
| Patient Reported Quality of Life - EQ-5D | Baseline, Day 30 and 12 Months | EuroQol Group EQ-5D-5L |
| Procedure Time | 24 hours | Total time from arterial access to removal of last catheter in minutes |
| Contrast Dose | 24 hours | Total amount of contrast used in ml |
| Radiation Dose | 24 hours | Total amount of radiation in Gy |
| Resource utilization | 24 hours | 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). |
| Cost-effectiveness | 12 Months | Cumulative healthcare cost in dollars for every major adverse event avoided |
| FFRangio Usability | 24 hours | Ability to conduct the FFRangio assessment without any system malfunction |
| Pressure Wire Usability | 24 hours | Ability to conduct the pressure wire based assessment without any system malfunction |
Countries
Israel, Japan, Switzerland, United Kingdom, United States
Contacts
STUDY_CHAIRAjay J Kirtane, MD, SM
NewYork-Presbyterian/Columbia University Irving Medical Center
PRINCIPAL_INVESTIGATORWilliam F Fearon, MD
Stanford University
PRINCIPAL_INVESTIGATORAllen Jeremias, MD, MSc
St. Francis Hospital & Heart Center
STUDY_CHAIRMartin B Leon, MD
NewYork-Presbyterian/Columbia University Irving Medical Center
Outcome results
None listed