RecruitingNCT06250790

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

Selective Coronary Revascularization in Peripheral Artery Disease Patients After Lower-extremity Revascularization (SCOREPAD Trial)

Sponsor

Pauls Stradins Clinical University Hospital

Enrollment

600 participants

Start Date

Feb 15, 2024

Study Type

OBSERVATIONAL

Conditions

Peripheral Arterial Disease Coronary Artery Disease

Summary

The primary objective of this study is to determine whether among symptomatic Peripheral Arterial Disease (PAD) patients with no known Coronary Artery Disease (CAD) who had undergone lower-extremity revascularization, a strategy of best medical therapy (BMT) plus selective coronary revascularization based on FFRct assessment of lesion-specific coronary ischemia can reduce adverse cardiac events and improve survival compared to BMT alone. Lesion-specific coronary ischemia is defined as FFRCT ≤0.80 distal to stenosis in a major (≥2 mm) coronary artery with severe ischemia defined as FFRCT ≤0.75.

Eligibility

Min Age: 50 Years

Inclusion Criteria3

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.

Exclusion Criteria15

Known CAD, history of MI, prior coronary revascularization (PCI or CABG);
Patient underwent coronary angiography or coronary CTA before the randomization;
Known history of 2nd or 3rd degree heart block; sick sinus syndrome; long QT syndrome;
History of severe asthma, severe or bronchodilator-dependent Chronic obstructive pulmonary disease (COPD);
Severe congestive heart failure (NYHA III or IV);
Severe arrhythmia, prior pacemaker or internal defibrillator lead implantation;
Impaired chronic renal function (EPI-Glomerular Filtration Rate (GFR)<30ml/min);
Subjects with known anaphylactic allergy to iodinated contrast;
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;
Any active, serious, life-threatening disease with a life expectancy of less than 2 years;
Any active infection;
Inability to comply with study procedures;
Contraindication for guideline-guided longterm antiplatelet/anticoagulation regime after PCI/CABG;
Participation in any interventional clinical study within 30 days prior to screening.

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Interventions

DIAGNOSTIC_TESTCoronary CT angiography and FFRct analysis

A new non-invasive cardiac diagnostic test, coronary CT-derived fractional flow reserve (FFRCT) provides a unified anatomic and functional assessment of coronary artery disease which can reliably identify ischemia-producing coronary lesions. FFRCT accurately reflects invasively measured FFR and can help guide patient management and coronary revascularization decisions.