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| Name | Class |
|---|---|
| Cardiovascular Research Foundation, New York | OTHER |
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To test whether FFRangio-guided treatment is non-inferior to conventional pressure wire-guided treatment in patients with coronary artery disease.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FFRangio | Experimental | FFRangio guided revascularization |
|
| Pressure wire | Active Comparator | Pressure wire-based guided revascularization (FFR or NHPR) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FFRangio | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| MACE | Rate of the composite of all-cause death, myocardial infarction (MI) or unplanned clinically-driven revascularization | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| All-Cause Mortality | Total rate of death from any cause | 12 months |
| Myocardial Infarction | Total rate of myocardial infarction | 12 months |
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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:
Angiographic Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ajay J Kirtane, MD, SM | NewYork-Presbyterian/Columbia University Irving Medical Center | Study Chair |
| William F Fearon, MD | Stanford University | Principal Investigator |
| Allen Jeremias, MD, MSc | St. Francis Hospital & Heart Center | Principal Investigator |
| Martin B Leon, MD | NewYork-Presbyterian/Columbia University Irving Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Diego Health | La Jolla | California | 92037 | United States | ||
| VA- Long Beach Healthcare |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41910384 | Derived | Fearon WF, Jeremias A, Witberg G, Al-Lamee R, Cohen DJ, Kaki A, Sharma RP, Yeh RW, Chehab BM, Kim MC, Otake H, Tayal R, Matsuo H, McEntegart M, Patel AK, Sandoval Y, Al-Azizi KM, Dan K, Razzouk L, Fournier S, Popma A, Popma JJ, Zhao D, Redfors B, Madhavan MV, Kornowski R, Leon MB, Kirtane AJ; ALL-RISE Investigators. Angiography-Derived Fractional Flow Reserve to Guide PCI. N Engl J Med. 2026 Mar 29. doi: 10.1056/NEJMoa2600949. Online ahead of print. | |
| 40828315 |
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| FFR or NHPR | Device | Using an invasive pressure-wire to assess functional significance of coronary lesions either under hyperemic conditions (FFR) or utilizing Non-hyperemic pressure ratios (NHPR). |
|
|
| Unplanned Revascularization | Total rate of unplanned clinically-driven revascularization | 12 months |
| Stent thrombosis | Total rate of definite or probable stent thrombosis | 12 months |
| Peri-Procedural Complications | Rate of peri-procedural complications defined as angiographic complications in the study vessel. | 30 Days |
| Stroke | Rate of disabling stroke | 30 Days |
| Bleeding | Rate of Major bleeding | 30 Days |
| Kidney Injury | Rate of Acute kidney injury (AKI) | 30 Days |
| Patient Reported Health Status - SAQ-7 | Seattle Angina Questionnaire (SAQ-7) | Baseline, Day 30 and 12 Months |
| Patient Reported Quality of Life - EQ-5D | EuroQol Group EQ-5D-5L | Baseline, Day 30 and 12 Months |
| Procedure Time | Total time from arterial access to removal of last catheter in minutes | 24 hours |
| Contrast Dose | Total amount of contrast used in ml | 24 hours |
| Radiation Dose | Total amount of radiation in Gy | 24 hours |
| 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 |
| Cost-effectiveness | Cumulative healthcare cost in dollars for every major adverse event avoided | 12 Months |
| FFRangio Usability | Ability to conduct the FFRangio assessment without any system malfunction | 24 hours |
| Pressure Wire Usability | Ability to conduct the pressure wire based assessment without any system malfunction | 24 hours |
| Long Beach |
| California |
| 90822 |
| United States |
| Keck Medicine of USC | Los Angeles | California | 90033 | United States |
| UCLA Medical Center | Los Angeles | California | 90095 | United States |
| Stanford University | Palo Alto | California | 94305 | United States |
| VA - Palo Alto Healthcare | Palo Alto | California | 94305 | United States |
| Kaiser Permanente San Francisco | San Francisco | California | 94118 | United States |
| St. Joesph's Medical Center | Stockton | California | 95204 | United States |
| HCA Florida JFK Hospital | Atlantis | Florida | 33462 | United States |
| Cardiac & Vascular Institute | Gainesville | Florida | 32605 | United States |
| University of Miami | Miami | Florida | 33136 | United States |
| HCA Florida Northside Hospital | St. Petersburg | Florida | 33709 | United States |
| Tallahassee Research Institute | Tallahassee | Florida | 32308 | United States |
| University of South Florida | Tampa | Florida | 33606 | United States |
| Archbold Hospital | Thomasville | Georgia | 31792 | United States |
| Carle Foundation Hospital | Urbana | Illinois | 61801 | United States |
| Ascension Via Christi St. Francis | Wichita | Kansas | 67214 | United States |
| Kansas Heart Hospital | Wichita | Kansas | 67226 | United States |
| St. Elizabeth Healthcare | Edgewood | Kentucky | 41017 | United States |
| Medstar Union Memorial Hospital | Baltimore | Maryland | 21218 | United States |
| TidalHealth, INC | Salisbury | Maryland | 21801 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Ascension St. John Hospital | Detroit | Michigan | 48236 | United States |
| Metropolitan Heart Vascular Institute | Coon Rapids | Minnesota | 55433 | United States |
| Minneapolis Heart Institute Foundation | Minneapolis | Minnesota | 55407 | United States |
| Cardiac Associates Research | Tupelo | Mississippi | 38801 | United States |
| Mountainside Medical Center | Montclair | New Jersey | 07042 | United States |
| Morristown Medical Center | Morristown | New Jersey | 07960 | United States |
| The Valley Hospital | Ridgewood | New Jersey | 07450 | United States |
| New York Presbyterian Methodist Hospital | Brooklyn | New York | 11215 | United States |
| NYU Langone Health | New York | New York | 10016 | United States |
| Columbia University Medical Center / New York Presbyterian Hospital | New York | New York | 10032 | United States |
| New York Presbyterian / Weill Cornell Medical Center | New York | New York | 10065 | United States |
| Northwell Health (Lenox Hill, North Shore, South Shore, Huntington, Staten Island)) | New York | New York | 10075 | United States |
| St. Francis Hospital and Heart Center | Roslyn | New York | 11576 | United States |
| Ellis Hospital | Schenectady | New York | 12308 | United States |
| The Christ Hospital | Cincinnati | Ohio | 45219 | United States |
| Mount Carmel Health System | Columbus | Ohio | 43219 | United States |
| Lehigh Valley Health | Allentown | Pennsylvania | 18103 | United States |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Baylor Scott & White The Heart Hospital - Plano | Plano | Texas | 75093 | United States |
| HCA Methodist Healthcare of San Antonio | San Antonio | Texas | 78249 | United States |
| Inova Fairfax Hospital | Fairfax | Virginia | 22031 | United States |
| Golda HaSharon Hospital | Petah Tikva | 49372 | Israel |
| Rabin Medical Centre | Petah Tikva | 4941492 | Israel |
| Fukuyama Cardiovascular Hospital | Fukuyama | Japan |
| Gifu Heart Center | Gifu | Japan |
| Ichinomiyanishi Hospital | Ichinomiya | Japan |
| Kobe University | Kobe | Japan |
| Chibanishi General Hospital | Matsudo | Japan |
| Mie University Hospital | Osaka | Japan |
| NTT Medical Center Tokyo | Tokyo | Japan |
| Sakakibara Heart Institute | Tokyo | Japan |
| Hopitaux Universitaires Geneve (HUG) | Geneva | Switzerland |
| centre hospitalier universitaire vaudois (CHUV) | Lausanne | CH-1011 | Switzerland |
| Hôpital Cantonal de Fribourg (HFR) | Villars-sur-Glâne | Switzerland |
| Basildon University Hospital | Basildon | United Kingdom |
| Imperial College Healthcare | London | W12 0HS | United Kingdom |
| Musgrove Park Hospital | Taunton | United Kingdom |
| Derived |
| Redfors B, Madhavan MV, Kirtane AJ, Fearon WF, Yeh RW, Cohen DJ, Al-Lamee R, Jeremias A, Witberg G, Sharma RP, Popma A, Kaki A, Froimovich A, Leon MB. FFRangio-guided versus pressure wire-guided PCI: design and rationale of the multicentre, randomised ALL-RISE trial. EuroIntervention. 2025 Aug 18;21(16):961-969. doi: 10.4244/EIJ-D-25-00200. |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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