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NCT05893498Active, not recruiting

Advancing Cath Lab Results With FFRangio Coronary Physiology Assessment

Source: ClinicalTrials.gov · Last updated 10 Mar 2026

Brief summary (registry, in English)

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

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
1924 (estimated)
First submitted
25 Apr 2023
Start date
21 Jun 2023
Primary completion date
May 2026
Lead sponsor
CathWorks Ltd.
NCT number
NCT05893498

What you commit to

  • Study type: Interventional
  • Planned participants: 1924
  • From 21 Jun 2023 to the primary completion date, May 2026
  • 59 sites in 5 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

  • 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:
  • Subject with ST-elevation (MI (STEMI) within 72 hours at time of study enrollment
  • Prior coronary artery bypass graft (CABG) with patent grafts to the study vessel(s)
  • Patients undergoing coronary physiologic assessment where one possible outcome is referral for CABG
  • The study vessel supplies a significant nonviable territory (e.g., prior transmural MI)
  • Severe left sided valvular heart disease
  • Most recent documented LVEF ≤30%
  • Women who are pregnant or breastfeeding (women of childbearing potential are required to have negative pregnancy test within 1 week of index procedure)
  • Patients with life expectancy \<1 year life as estimated by treating physician.
  • 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)
  • Subjects who have undergone angiographic or wire-based coronary physiological assessment for 1 or more potential study lesions within 30 days of enrollment.
    • Angiographic Exclusion Criteria:
  • Coronary angiogram is not acquired per instructions as defined in the Study Protocol
  • Sthe study lesion is the clear culprit for a NSTEACS
  • Angiographic evidence of a procedural complication (e.g., acute stent thrombosis, flow-limiting dissection, perforation, slow/no reflow, or other) prior to randomization
  • Thrombolysis in myocardial infarction (TIMI) Grade 2 flow or lower in any study vessel at time of enrollment
  • The study vessel is in a left coronary vessel with separate left anterior descending and left circumflex ostia arising from the aorta
  • The study lesion involves the left main coronary artery (stenosis ≥ 50%)
  • The study lesion is in an ectatic or aneurysmal coronary segment (defined as lumen diameter 1.5x diameter or the reference vessel)

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (59)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hôpitaux Universitaires Genève HUG
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GenevaSwitzerlandUnknown status
Centre Hospitalier Universitaire Vaudois (CHUV)
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LausanneSwitzerlandUnknown status
Hôpital Cantonal de Fribourg (HFR)
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Villars-sur-GlâneSwitzerlandUnknown status
Basildon University Hospital
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BasildonUnited KingdomUnknown status
Imperial College Healthcare
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LondonUnited KingdomUnknown status
Musgrove Park Hospital
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TauntonUnited KingdomUnknown status
Rabin Medical Centre
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Petah TikvaIsraelUnknown status
Golda HaSharon Hospital
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Petah TikvaIsraelUnknown status
Fukuyama Cardiovascular Hospital
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FukuyamaJapanUnknown status
Gifu Heart Center
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GifuJapanUnknown status
Ichinomiyanishi Hospital
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IchinomiyaJapanUnknown status
Kobe University
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KobeJapanUnknown status
Chibanishi General Hospital
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MatsudoJapanUnknown status
Mie University Hospital
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OsakaJapanUnknown status
Sakakibara Heart Institute
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TokyoJapanUnknown status
NTT Medical Center Tokyo
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TokyoJapanUnknown status
Lehigh Valley Health
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AllentownUnited StatesUnknown status
HCA Florida JFK Hospital
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AtlantisUnited StatesUnknown status
MedStar Union Memorial Hospital
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BaltimoreUnited StatesUnknown status
Beth Israel Deaconess Medical Center
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BostonUnited StatesUnknown status
New York Presbyterian Methodist Hospital
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BrooklynUnited StatesUnknown status
The Christ Hospital
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CincinnatiUnited StatesUnknown status
Mount Carmel Health System
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ColumbusUnited StatesUnknown status
Metropolitan Heart Vascular Institute
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Coon RapidsUnited StatesUnknown status
Ascension St. John Hospital
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DetroitUnited StatesUnknown status
St. Elizabeth Healthcare
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EdgewoodUnited StatesUnknown status
Inova Fairfax Hospital
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FairfaxUnited StatesUnknown status
Cardiac & Vascular Institute
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GainesvilleUnited StatesUnknown status
University of California San Diego Health
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La JollaUnited StatesUnknown status
VA- Long Beach Healthcare
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Long BeachUnited StatesUnknown status
UCLA Medical Center
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Los AngelesUnited StatesUnknown status
Keck Medicine of USC
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Los AngelesUnited StatesUnknown status
University of Miami
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MiamiUnited StatesUnknown status
Minneapolis Heart Institute Foundation
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MinneapolisUnited StatesUnknown status
Mountainside Medical Center
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MontclairUnited StatesUnknown status
Morristown Medical Center
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MorristownUnited StatesUnknown status
New York - Presbyterian - Weill Cornell Medical Center
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New YorkUnited StatesUnknown status
Columbia University Medical Center/New York-Presbyterian Hospital
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New YorkUnited StatesUnknown status
NYU Langone Health
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New YorkUnited StatesUnknown status
Northwell Health (Lenox Hill, North Shore, South Shore, Huntington, Staten Island))
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New YorkUnited StatesUnknown status
Stanford University
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Palo AltoUnited StatesUnknown status
VA - Palo Alto Healthcare
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Palo AltoUnited StatesUnknown status
Hospital of the University of Pennsylvania
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PhiladelphiaUnited StatesUnknown status
Baylor Scott & White The Heart Hospital - Plano
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PlanoUnited StatesUnknown status
The Valley Hospital
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RidgewoodUnited StatesUnknown status
St. Francis Hospital and Heart Center
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RoslynUnited StatesUnknown status
TidalHealth, INC
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SalisburyUnited StatesUnknown status
HCA Methodist Healthcare of San Antonio
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San AntonioUnited StatesUnknown status
Kaiser Permanente-San Francisco
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San FranciscoUnited StatesUnknown status
Ellis Hospital
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SchenectadyUnited StatesUnknown status
St. Joesph's Medical Center
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StocktonUnited StatesUnknown status
HCA Florida Northside Hospital
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St. PetersburgUnited StatesUnknown status
Tallahassee Research Institute
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TallahasseeUnited StatesUnknown status
University of South Florida
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TampaUnited StatesUnknown status
Archbold Hospital
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ThomasvilleUnited StatesUnknown status
Cardiac Associates Research
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TupeloUnited StatesUnknown status
Carle Foundation Hospital
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UrbanaUnited StatesUnknown status
Kansas Heart Hospital
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WichitaUnited StatesUnknown status
Ascension Via Christi St. Francis
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WichitaUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.