Radiographic Imaging Validation and EvALuation for Angio iFR (ReVEAL iFR)

Coronary Artery Disease Clinical Trial

— ReVEAL  

Official title:

Radiographic Imaging Validation and EvALuation for Angio iFR (ReVEAL iFR)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03857503
• Other study ID #: 180102
• Status: Completed
• Start date: August 1, 2019
• Est. completion date: March 12, 2021

Study information

• Verified date: March 2021
• Source: Volcano Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

This study is intended to demonstrate the diagnostic performance of the image-derived physiology model using the invasive physiological measures as the reference standard.

Specific objectives include the following:

i) Demonstrate the sensitivity and specificity of image-derived iFR and FFR results for identifying functionally significant lesions as determined by the corresponding invasive measures; ii) Demonstrate the diagnostic agreement of image-derived iFR and FFR estimates with the corresponding invasive measures; iii) Demonstrate the diagnostic performance of image derived physiology estimate (iFR/FFR) is superior to visual angiographic assessment for the identification of functionally significant stenoses as determined by the corresponding invasive physiology measures; iv) Demonstrate reproducibility of the image-derived estimate for a given operator and across multiple operators for a given lesion.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Cardiac Ischemia
• Coronary Artery Disease
• Coronary Stenosis
• Ischemia
• Myocardial Ischemia

Intervention

Diagnostic Test:
• iFR
Patients will undergo standard of care diagnostic coronary angiography using established invasive physiological criteria for iFR and FFR to aid in clinical decision making for coronary revascularization. Angiograms will be made in at least two projections, and the treating physician will record his/her estimation of stenosis severity. Resting iFR and Pd/Pa measures will then be made distal to the target lesion; adenosine will be administered, and the FFR measures will be made without moving the wire. An iFR pullback will then be made after hyperemia as abated. Patients will be treated or deferred from treatment based on physician decision aided by the iFR measures.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Volcano Corporation

Countries where clinical trial is conducted

United States,  Germany,  Ireland,  Japan,  Netherlands,  Spain,  United Kingdom, 

Outcome

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