NCT06250790

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

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 600 (estimated)
• Sponsor: Pauls Stradins Clinical University Hospital · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study targets a population of 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 computed tomography angiography (CTA), and no coronary revascularization (PCI or CABG) who have undergone successful lower extremity revascularization with planned post-operative best medical therapy. Within 14 days following lower-extremity revascularization, patients will be randomly assigned to BMT alone or BMT plus coronary CT angiography (which must be completed within 14 days of randomization) and Fractional Flow Reserve Derived from CT (FFRct) analysis to determine the functional significance of coronary lesions identified on the CT scan. Results of the CT scan and FFRCT analysis in patients randomized to the CT-FFRct group, will be provided to treating physicians to help guide patient management with Heart Team consideration for coronary angiography and revascularization as appropriate for each patient. Coronary revascularisation (PCI or CABG), if indicated, is strongly recommended within 3 months from the randomisation. Clinical follow up (based on date of randomization) is planned 6 months, one and 2 years. Additional long-term follow up out to 5-years is planned for participating centers. An independent academic clinical events committee will adjudicate all endpoints in a blinded manner. The definition of outcome events will be in accordance with Academic Research Consortium-2 consensus document.

Conditions

• Peripheral Arterial Disease
• Coronary Artery Disease

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Coronary 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.

Timeline

• Start date: 2024-02-15
• Primary completion: 2026-02-15
• Completion: 2029-02-15
• First posted: 2024-02-09
• Last updated: 2024-02-16

Locations

1 site across 1 country: Latvia