NCT06387355

Diagnosis and Treatment of CAD in Severe PAD After Lower Extremity Revascularization

Diagnosis and Treatment of Coronary Artery Disease in Severe Peripheral Artery Disease After Lower Extremity Revascularization

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: VA Office of Research and Development · Federal
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Peripheral artery disease, lack or blood flow to the legs, has a high prevalence in the Veteran population. In patients with severe peripheral artery disease that requires an endovascular or surgical intervention for lower leg revascularization, the long-term mortality of approximately 50% is worse that most cancers. The goal of this study is to develop a management strategy to improve cardiovascular outcomes in this high-risk peripheral artery disease population after lower extremity revascularization.

Detailed description

This study will be to conduct a randomized, controlled, multi-center clinical trial to evaluate a non-invasive management strategy of a computed topography (CT) scan of the coronary arteries and computational analysis of coronary perfusion with selective coronary revascularization plus optimal medical therapy compared to optimal medical therapy. Therefore, this study will provide the opportunity for Veterans to participate in a clinical trial to reduce the very high cardiac-related mortality rate in this population.

Conditions

• Peripheral Artery Disease
• Coronary Artery Disease

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Coronary computed topography (CT) angiography with FFR-CT	The investigational treatment strategy will have a coronary CT angiography diagnostic imaging with computational analysis FFR-CT (Fractional Flow Reserve from the coronary CTA)

Timeline

• Start date: 2024-11-01
• Primary completion: 2024-11-01
• Completion: 2024-11-01
• First posted: 2024-04-29
• Last updated: 2025-09-26

Locations

7 sites across 1 country: United States