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…
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Diagnostic accuracy of the image-derived iFR and FFR estimate for a given
lesion compared to the corresponding invasive iFR and FFR yields a sensitivity
* 75% and specificity * 80%
Secondary outcome
* Diagnostic agreement between the angiographic derived iFR/FFR estimate and
the reference invasive measure for the same lesion is within the inherent
measurement variability
* Superior specificity of the iFR/FFR estimate over visual determination of
stenosis severity based on the angiogram alone (i.e., *50% diameter stenosis)
* Inter- and intra-observer diagnostic and measurement agreement between
repeated estimates made by the medical software device for a given lesion
* Diagnostic agreement measures:
* Diagnostic accuracy
* Positive (PPV) and negative predictive values (NPV)
* Area under the Received Operating Characteristics (ROC) curve (AUC)
* Positive and negative likelihood ratios
* Diagnostic odds ratio
Background 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.
Study objective
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.
Study design
Multi-center, prospective, single-arm, open-label, data collection with
centralized off-line data analysis
Study burden and risks
In addition to the minimal risks, as described in E9, there is no impact on the
patient or his treatment in this observational diagnostic study. The knowledge
obtained through this study can ensure a less invasive diagnosis in the future.
3721 Valley Centre Drive, Suite 500 500
San Diego 92130
US
3721 Valley Centre Drive, Suite 500 500
San Diego 92130
US
Listed location countries
Age
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 that may
acutely impact microvascular function at the time of the physiology procedure
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | 03857503 |
| CCMO | NL69439.099.19 |