Performance of a New REsting Pressure Index During Invasive Angiography Compared To Adenosine Hyperemic FFR

Study Overview
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Brief Summary
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To test the feasibility and diagnostic accuracy of a new automated pressure derived resting index (Pd/Pamin), using FFR as gold standard, in de novo coronary lesions in which invasive physiological evaluation is warranted.

Detailed Description
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Coronary lesions with a potential indication for percutaneous coronary intervention or warranting invasive physiological interrogation (in the opinion of the investigator) will undergo PressureWire™ assessment under 2 conditions: rest and adenosine hyperemia. The measurements at rest (standard Pd/Pa and Pd/Pamin) will be repeated to assess test/retest repeatability. Subsequent treatment decisions will be made by the operator according to the standard practice based on the adenosine FFR value together with all other clinical information.

Official Title
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Performance of a New REsting Pressure Index During Invasive Angiography Compared To Adenosine Hyperemic FFR

Conditions
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Fractional Flow Reserve, Myocardial, Coronary Artery Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing FFR assessment for standard clinical indications, according to individual operator decision. Age ≥ 18 years. Provided signed written informed consent for data collection the collection. De novo coronary artery disease in target vessel. Single or multiple vessel disease. Patient eligible for elective or ad hoc PCI (or CABG), if revascularization is deemed indicated, in the setting of stable coronary artery disease or non-culprit lesions of non-ST elevation acute coronary syndromes (only in deferred procedures). Stenosis deemed amenable for both evaluation with a pressure wire and for potential revascularization. Exclusion Criteria: Subjects with restenosis in the target vessel. Known severe renal insufficiency (examples being but not limited to eGFR <30 ml/kg/min, serum creatinine ≥ 2.5 mg/dL or on dialysis). Aorto-ostial lesion location within 3 mm of the aorta junction (both right and left). Vessel(s) and lesion(s) not amenable for evaluation with a PressureWire™ and/or revascularization. Tandem lesions Moderate lesions in patients with multivessel disease in whom at least one lesion in another major epicardic vessel is severe (to minimize lesion interaction), unless the severe lesion is treated first (see above). Left ventricular ejection fraction <50% Known severe left ventricular hypertrophy Atrial fibrillation or any other significant arrhythmia (including an heart rate <50/min on sinus rhythm) Systolic blood pressure <90 mmHg. Any other medical condition that in the opinion of the investigator will interfere with patient safety or study results Currently participating in another clinical study that interferes with study results. Pregnant or nursing females Planned or prior heart transplantation or listed for heart transplant. Any condition that precludes the subject from undergoing PCI or any of the protocol mandated procedures, for example subjects with a prior history heparin induced thrombocytopenia, known intolerance to adenosine or with a contra-indication for dual anti-platelet therapy. Patients with severe valvular disease Patients with severe pulmonary disease Culprit lesions in ACS patients are not to be included nor non-culprit lesions in patients with a recent STEMI undergoing staged procedures. Patients with a CTO, regardless of the presence and the extent of angiographic collaterals from the target vessel.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Prospective cohort<br>Prospective cohort of patients with stable or stabilized coronary artery disease and de novo coronary lesions, in whom functional evaluation is performed, according do standard clinical indications. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy of Pd/Pamin vs FFR | Agreement will be tested using the established FFR 0.8 threshold as the binary reference standard. | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Discriminative power of Pd/Pamin and the best cut-off, taking FFR as gold | ROC analysis using FFR as reference | baseline | 
| Feasibility of Pd/Pamin measurements | Description of how often can Pd/Pamin can be measured accurately | Baseline |