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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
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• 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.

Locations
Other Locations
Latvia
Pauls Stradins Clinical University hospital
RECRUITING
Riga
Contact Information
Primary
Dainis Krievins, MD, PhD
dainis.krievins@gmail.com
+371 29450000
Time Frame
Start Date: 2024-02-15
Estimated Completion Date: 2029-02-15
Participants
Target number of participants: 600
Treatments
Assigned to Best Medical Therapy (BMT) alone
Patients who have undergone successful lower extremity revascularization and are assigned to BMT alone within 14 days following revascularization.
Assigned to Best Medical Therapy (BMT) + coronary CT angiography + CT-FFRct analysis
Patients who have undergone successful lower extremity revascularization and are assigned to BMT plus coronary CT angiography (which must be completed within 14 days of randomization) and FFRct analysis to determine the functional significance of coronary lesions identified on the CT scan.
Sponsors
Leads: Pauls Stradins Clinical University Hospital

This content was sourced from clinicaltrials.gov

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