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

ConditionsPeripheral Arterial Disease Coronary Artery Disease

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age50+

SponsorPauls Stradins Clinical University Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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);

Trial population

Patients with symptomatic PAD (CLTI or severe claudication in 1:1 ratio) and no prior cardiac history, no myocardial infarction, no coronary angiography or coronary CTA, and no coronary revascularization (PCI or CABG) who have undergone successful lower extremity revascularization with planned post-operative best medical therapy.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Coronary CT angiography and FFRct analysis
Diagnostic test
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.

Treatment groups

600 Participants

are divided into 2 treatment groups

Group A: Assigned to Best Medical Therapy (BMT) alone0 interventions

Group B: Assigned to Best Medical Therapy (BMT) + coronary CT angiography + CT-FFRct analysis1 intervention

Trial outcomes

Primary outcomes

Major Adverse Cardiac Events

A composite of cardiac death, myocardial infarction (MI) or urgent coronary revascularization

Time frame

2 years

Secondary outcomes

Major Adverse Cardiac Events and survival

Cardiac death, cardiovascular death, myocardial infarction (MI), urgent coronary revascularisation, all-cause death

Time frame

2 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Pauls Stradins Clinical University Hospital

Lead sponsor

Source ClinicalTrials.gov

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