Ignite Creation Date:
2024-05-06 @ 8:07 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06250790
Status:
RECRUITING
Last Update Posted:
2024-02-16
First Post:
2024-02-01
Brief Title:
Selective Coronary Revascularization in Peripheral Artery Disease Patients SCOREPAD Trial
Sponsor:
Pauls Stradins Clinical University Hospital
Organization:
Pauls Stradins Clinical University Hospital
Study Overview
Official Title:
Selective Coronary Revascularization in Peripheral Artery Disease Patients After Lower-extremity Revascularization SCOREPAD Trial
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 080 distal to stenosis in a major 2 mm coronary artery with severe ischemia defined as FFRCT 075
Detailed Description:
This study targets a population of patients with symptomatic PAD CLTI or severe claudication in 11 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None