Precise Percutaneous Coronary Intervention Plan (P3) Study

Study Overview
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Brief Summary
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The PRECISE PERCUTANEOUS CORONARY INTERVENTION (PCI) PLAN STUDY is an investigator-initiated, international and multicenter study of patients with an indication for PCI aiming at assessing the agreement and accuracy of the HeartFlow Planner with invasive fractional flow reserve (FFR) as a reference.

Detailed Description
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Multicenter study, including 120 patients at 5 centers in Europe and Asia. After identifying the presence of significant coronary stenosis by means of coronary angiography and invasive fractional flow reserve (FFR≤0.80) the patients will undergo the following procedures: Invasive FFR with intravenous adenosine (i.e. pre- and post-PCI). Optical coherence tomography-guided PCI (i.e. pre- and post-procedural imaging). PCI with newer generation drug-eluting stent.

Official Title
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Prospective Evaluation of a Virtual Non-invasive Percutaneous Intervention Planner in Patients With Coronary Artery Disease.

Conditions
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Stable Coronary Artery Disease

Intervention / Treatment
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* Diagnostic Test: FFRCT planner


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Coronary artery disease in a major epicardial vessel with an invasive fractional flow reserve (FFR) ≤0.80 An indication to Percutaneous coronary intervention Exclusion Criteria: - Angiographic exclusion criteria Severely calcified lesion/vessel Bifurcation lesions. Ostial lesions. Left main disease. Severe vessel tortuosity. Clinical exclusion criteria Chronic obstructive pulmonary disease Contraindication to adenosine NYHA class III or IV, or last known left ventricular ejection fraction <30% Uncontrolled or recurrent ventricular tachycardia Atrial fibrillation, flutter or arrhythmia History of recent stroke (≤90 days) History of acute coronary syndrome (≤90 days) Prior myocardial infarction History of ischemic stroke (>90 days) with modified RANKIN score ≥ 2 History of any hemorrhagic stroke Previous revascularization (PCI or Coronary artery bypass grafting) Active liver disease or hepatic dysfunction, defined as AST or ALT > 3 times the ULN Severe renal dysfunction, defined as an eGFR <30 mL/min/1.73 m2 Body mass index>35 kg/m2 Nitrate intolerance Contra-indication to heart rate lowering drugs Imaging-related Insufficient coronary CT Angiography image quality.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Single-arm cohort<br>Patients with significant coronary stenosis by invasive fractional flow reserve (FFR≤0.80) | Diagnostic Test: FFRCT planner<br>* Non-invasive post-PCI fractional flow reserve prediction<br>* Other names: HeartFlow Planner;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Agreement on post-PCI fractional flow reserve between virtual treatment based on FFRct planner and measured invasive post-PCI fractional flow reserve. | The agreement will be assessed by Bland Altman method | The primary endpoint will be assessed immediately after the procedure (PCI). |