Selective Coronary Revascularization in Peripheral Artery Disease Patients (SCOREPAD Trial)

Prior treatment

• Known CAD, history of MI, prior coronary revascularization (PCI or CABG);
• Severe arrhythmia, prior pacemaker or internal defibrillator lead implantation;
• Participation in any interventional clinical study within 30 days prior to screening.

Other illness

• History of severe asthma, severe or bronchodilator-dependent Chronic obstructive pulmonary disease (COPD);
• Severe congestive heart failure (NYHA III or IV);
• Subjects with known anaphylactic allergy to iodinated contrast;
• Any active, serious, life-threatening disease with a life expectancy of less than 2 years;
• Any active infection;

Lab values

• Known history of 2nd or 3rd degree heart block; sick sinus syndrome; long QT syndrome;
• Impaired chronic renal function (EPI-Glomerular Filtration Rate (GFR)\<30ml/min);

Other

• Patient underwent coronary angiography or coronary CTA before the randomization;
• Pregnancy or unknown pregnancy status in subject of childbearing potential;
• Evidence of ongoing or active clinical instability, including acute chest pain (sudden onset), cardiogenic shock, unstable blood pressure with systolic blood pressure \<90 mmHg, or acute pulmonary edema;
• Inability to comply with study procedures;
• Contraindication for guideline-guided longterm antiplatelet/anticoagulation regime after PCI/CABG;

• Inform consent obtained before any study-related activities;
• Age above or equal to 50 years with symptomatic lower extremity PAD (severe claudication or chronic limb-threatening ischemia, Rutherford 3,4,5) which has been successfully revascularized by open surgical or endovascular procedure within the past 14 days;
• Willing and able to undergo coronary CTA scan within 14 days of randomization and agrees to submission of CTA data set for HeartFlow FFRct analysis with results made available to treating physician.