Fast Assessment of STenosis Severity- FASTII Study
| Status: | Recruiting |
|---|---|
| Conditions: | Peripheral Vascular Disease, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/3/2019 |
| Start Date: | October 15, 2018 |
| End Date: | November 1, 2019 |
| Contact: | Joost Daemen, MD;PhD. |
| Email: | j.daemen@erasmusmc.nl |
| Phone: | +31 10 703 5260 |
Multicenter Validation of 3D-QCA Based FFR vs. Pressure Wire Based FFR: The FAST-II Study
The Multicenter FAST (Fast Assessment of STenosis severity) study is a prospective
observational multicenter study designed to evaluate the diagnostic accuracy of offline
3D-QCA based FFR, using CAAS Workstation (Pie Medical Imaging, Maastricht, the Netherlands)
in identifying hemodynamically significant coronary artery disease with pressure wire-based
FFR (≤0.80) as the reference standard.
observational multicenter study designed to evaluate the diagnostic accuracy of offline
3D-QCA based FFR, using CAAS Workstation (Pie Medical Imaging, Maastricht, the Netherlands)
in identifying hemodynamically significant coronary artery disease with pressure wire-based
FFR (≤0.80) as the reference standard.
The Multicenter FAST study is a prospective observational multicenter international study in
which offline computation of vFFR is compared to conventional invasive, wire based FFR
measurements. Pressure wire based FFR will be performed in patients with at least one
intermediate coronary lesion at the discretion of the operator (typically defined as a
coronary artery lesion with a diameter stenosis of 30-70% by visual assessment). A total of 3
two-dimensional angiography images, will be recorded and exported to the CAAS workstation 8.0
(Pie Medical Imaging, Maastricht, the Netherlands): two orthogonal views to create a 3D
reconstruction of the coronary arteries and one view to ascertain the position of the FFR
pressure wire. vFFR will be calculated automatically, by using the invasively measured aortic
root pressure. vFFR measurements will be performed online by the different centers. In
addition, all angiographic imaging data will be sent to an independent core laboratory
(Cardialysis, Rotterdam, The Netherlands) for offline analysis.
which offline computation of vFFR is compared to conventional invasive, wire based FFR
measurements. Pressure wire based FFR will be performed in patients with at least one
intermediate coronary lesion at the discretion of the operator (typically defined as a
coronary artery lesion with a diameter stenosis of 30-70% by visual assessment). A total of 3
two-dimensional angiography images, will be recorded and exported to the CAAS workstation 8.0
(Pie Medical Imaging, Maastricht, the Netherlands): two orthogonal views to create a 3D
reconstruction of the coronary arteries and one view to ascertain the position of the FFR
pressure wire. vFFR will be calculated automatically, by using the invasively measured aortic
root pressure. vFFR measurements will be performed online by the different centers. In
addition, all angiographic imaging data will be sent to an independent core laboratory
(Cardialysis, Rotterdam, The Netherlands) for offline analysis.
Inclusion Criteria:
- patients ≥ 18 years
- indication procedure: stable, unstable angina or non-ST elevation acute coronary
syndrome
- Diagnostic coronary angiography or PCI with an indication to perform re-PCI FFR
assessment of at least one coronary artery lesion.
Exclusion Criteria:
- ST-elevation myocardial infarction (STEMI)
- Cardiogenic shock
- Severe hemodynamic instability
- Adenosine intolerance
- Lesions containing thrombus, left main lesions, grafts, arteries with collaterals
We found this trial at
2
sites
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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