Trial Parameters
Brief Summary
Recently, a new device for measuring physiological lesion severity, the pressure microcatheter, was introduced. The pressure microcatheter provides similar information to the conventional measurement technique but differs as it is easily advanced on a customary coronary wire and simplifies pullback maneuvers. The pressure microcatheter has been shown to provide comparable FFR results to pressure wires. Insightful-FFR is an investigator-driven, multicenter, randomized, open-label and prospective trial of patients with stable coronary artery disease or stabilised non-ST elevation acute coronary syndrome (ACS) with epicardial stenosis considered for PCI aiming at comparing clinical outcomes between pressure microcatheter and pressure wire-guided strategies. The study hypothesis states that the use of a Pressure Microcatheter for clinical decision making would be non-inferior to pressure wire-based strategy After determining the presence of a coronary artery disease/ stabilized acute coronary syndrome, patients will be randomized to use a pressure microcatheter (investigational device) or a pressure wire (comparator) to guide and optimize percutaneous coronary intervention (PCI). Patients will be followed up in hospital at 12 months and yearly until five years.
Eligibility Criteria
Inclusion Criteria: 1. The subject must be at least 18 years of age and younger than 85 years old. 2. Eligible for elective PCI. 3. Stable angina or ACS (non-culprit vessels only and outside of primary intervention during acute STEMI) 4. Subject willing to participate and able to understand, read and sign the Informed Consent. Exclusion Criteria: 1. STEMI as clinical presentation. 2. Chronic total occlusion as a target vessel. 3. Significant contraindication to adenosine administration (e.g. heart block, severe asthma) 4. Uncontrolled or recurrent ventricular tachycardia. 5. Hemodynamic instability. 6. Severe valvular disease. 7. Severe renal dysfunction defined as an eGFR ≤30 mL/min/1.73 m2. 8. Comorbidity with life expectancy ≤ 2 years. 9. Inability to take DAPT (both aspirin and a P2Y12 inhibitor) for at least 12 months in the patient presenting with an ACS, or at least six months in the patient presenting with stable CAD, unless the patient is also taking chronic oral anticoagulati