Coronary Artery Disease Clinical Trial
— ReVEALOfficial title:
Radiographic Imaging Validation and EvALuation for Angio iFR (ReVEAL iFR)
NCT number | NCT03857503 |
Other study ID # | 180102 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | August 1, 2019 |
Est. completion date | March 12, 2021 |
Verified date | March 2021 |
Source | Volcano Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The Philips Angio-iFR medical software device is intended to provide information on the functional significance of a coronary artery lesion to provide guidance on diagnostic decisions similar to that obtained through invasive measures of iFR and FFR. The software application uses the vessel geometry obtained from a coronary angiographic image together with a lumped parameter physiological model to provide the associated iFR and FFR estimates.
Status | Completed |
Enrollment | 441 |
Est. completion date | March 12, 2021 |
Est. primary completion date | March 12, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. =18 years old 2. At least 1 de-novo lesion in 1 or more major epicardial vessels of 40-90% angiographic stenosis with a reference vessel size =2.5mm in the diseased segment by visual estimate 3. Able and willing to provide informed consent Exclusion Criteria: 1. Presenting with an acute coronary syndrome (ACS), or documented ACS within 4 weeks prior to the scheduled index procedure 2. Cardiogenic shock (sustained (>10 min) systolic blood pressure <90 mmHg in absence of inotropic support or the presence of an intra-aortic balloon pump) 3. Presence of cardiac arrhythmias (e.g., atrial fibrillation, AV-block) 4. Prior cardiac surgery or implant, including CABG, heart transplant, surgical heart valve replacement or repair, TAVI/TAVR, presence of an ICD or pacemaker 5. Target vessel supplied by a left main coronary artery demonstrating any disease present (isolated or non-isolated) 6. Target vessel supplied by right coronary artery demonstrating any ostial disease (located immediately at the origin of the coronary vessels from the aorta) 7. Target vessel with Chronic Total Occlusion (CTO) in the ipsilateral territory or target vessel with an untreated CTO in the contralateral territory. Note: if a CTO existing in the contralateral territory is successfully opened, the target vessel in the contralateral territory can be included following CTO treatment. 8. Target vessel with severe tortuosity (=1 bends of 90° or more, or =3 or more bends of 45°- 90° proximal to the diseased segment) 9. Target vessel with heavy calcification (multiple persisting opacifications of the coronary wall visible in more than one projection surrounding the complete lumen of the coronary artery at the site of the lesion.) 10. Target vessel with TIMI flow grade 1 or 0 11. Target vessel with severe diffuse disease (more than 75% of the length of the segment having a vessel diameter of 2mm, irrespective of the presence or absence of a lesion) 12. Target lesion is at a bifurcation/trifurcation 13. Target arteries supplying akinetic or severely hypokinetic territories if already known based on prior imaging 14. Target vessel is supplied by major collaterals 15. Target stenosis associated with myocardial bridge 16. Any vascular abnormality precluding optimal contrast opacification (e,g, thrombus, ulceration) 17. Severe aortic or mitral valve disease 18. Known ejection fraction =30% 19. Known severe renal insufficiency (eGFR<30ml/min/1.72m2) 20. Any fluoroscopic interference that renders the wire position unclear 21. Contraindication for adenosine or other hyperemic agent (e.g., caffeine ingestion =18 hours, COPD, hypotension, AV block) 22. Known pregnancy or planning to become pregnant 23. Participating in another interventional investigational study |
Country | Name | City | State |
---|---|---|---|
Germany | Unversitatklinikum, Freiburg | Freiburg | |
Germany | Gemeinschaftsklinikum, Koblenz | Koblenz | |
Germany | Universitatklinikum, Mannheim | Mannheim | |
Germany | Robert-Bosch Krankenhaus, Stuttgart | Stuttgart | |
Ireland | University Hospital Galway, CRFG | Galway | |
Japan | Gifu Heart Center | Gifu | |
Japan | Ehime Medical University | Matsuyama | |
Japan | Wakayama Medical University | Wakayama | |
Netherlands | AMC Amsterdam | Amsterdam | |
Netherlands | Amphia Ziekenhuis Breda | Breda | |
Netherlands | Medische Spectrum Twente | Enschede | |
Netherlands | Medisch Centrum Leeuwarden | Leeuwarden | |
Netherlands | Sint Antonius Ziekenhuis | Nieuwegein | |
Netherlands | Radboud UMC | Nijmegen | |
Spain | Hospital Universitario de Léon | León | |
Spain | Hospital Clinico San Carlos | Madrid | |
United Kingdom | Basildon Univeristy Hospital | Basildon | |
United Kingdom | Blackpool Victoria hospital | Blackpool | |
United Kingdom | Royal Bournemouth hospital | Bournemouth | |
United Kingdom | Imperial College of London- Hammersmith Hospital | London | |
United Kingdom | University of Southampton | Southampton | |
United States | Emory University Hospital | Atlanta | Georgia |
United States | South Side Hospital | Bay Shore | New York |
United States | University at Buffalo | Buffalo | New York |
United States | Baylor Scott & White Research Institute | Dallas | Texas |
United States | Midwest Cardiovascular Research Foundation | Davenport | Iowa |
United States | Ascension St. John Hospital | Detroit | Michigan |
United States | Duke University Hospital | Durham | North Carolina |
United States | NC Heart & Vascular | Goldsboro | North Carolina |
United States | Memorial Regional Hospital | Hollywood | Florida |
United States | Colorado Heart and Vascular/St Anthony's | Lakewood | Colorado |
United States | VA Medical Center | Long Beach | California |
United States | Catholic Medical Center | Manchester | New Hampshire |
United States | Centennial Heart | Nashville | Tennessee |
United States | Yale University Hospital | New Haven | Connecticut |
United States | Integris Heart Hospital | Oklahoma City | Oklahoma |
United States | Memorial Hospital- West | Pembroke Pines | Florida |
United States | St Francis Hospital | Roslyn | New York |
United States | Bryn Mawr Hospital | Wynnewood | Pennsylvania |
United States | Lankenau Medical Center | Wynnewood | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Volcano Corporation |
United States, Germany, Ireland, Japan, Netherlands, Spain, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Diagnostic accuracy of the image-derived iFR | Diagnostic accuracy of the image-derived iFR and FFR estimate for a given lesion compared to the corresponding invasive iFR and FFR values. | 1 day |
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