Correlation of Machine Learning Computed Tomography-Based Fractional Flow Reserve (CT-FFRML) with Instantaneous Wave Free Ratio (iFR®) to Detect Hemodynamically Significant Coronary Stenosis
- Conditions
- Coronary artery diseaseI25.0Atherosclerotic cardiovascular disease, so described
- Registration Number
- DRKS00017160
- Lead Sponsor
- Volcano Europe BVBA/SPR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 40
• Clinical indication for cCTA.
• Indication for invasive assessment of coronary lesion depending on the result of
the cCTA.
• Stable coronary heart disease with coronary stenosis of unclear hemodynamic
relevance.
Significant valvular pathology
• Hemodynamic instability at the time of intervention
• High sensitive troponin I (>0,2 ng/ml)
• Severe vessel tortuosity and/or severe calcification by angiogram
• Time between cCTA and ICA procedures exceeding 1 month
• Contraindications for a cCTA/ICA (e.g. allergy to contrast agents, renal failure)
• Severely reduced left ventricular function
• Patients with prior coronary artery bypass grafting (CABG)
• Bifurcation stenosis types D to G (SYNTAX score classification)
• Severe stenosis of the proximal left main and/or the proximal right coronary artery
• Percutaneous coronary stent implantation in the vessel of interest
• Inadequate image quality of the cCTA dataset
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Diagnostic accuracy (sensitivity, specificity, negative predictive value, positive predictive value) of non invasive CT-FFR compared to invasive catheterbased iFR® in patients suspicious for coronacry artery disease. Both exams will be performed shortely after each other.
- Secondary Outcome Measures
Name Time Method Clinical practicability of CT-FFR.