Selective Coronary Revascularization in Peripheral Artery Disease Patients (SCOREPAD Trial)
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
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 design
Treatments tested in this trial
- Coronary CT angiography and FFRct analysis
Treatment groups
600 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov