CT Angiography for Peripheral Arterial Disease
(CAD in sPAD Trial)

Recruiting in Palo Alto (17 mi)

+6 other locations

Overseen byClay Quint, MD PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: VA Office of Research and Development

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for veterans with severe peripheral artery disease (PAD) who have undergone surgery or endovascular intervention to restore blood flow in their legs. Participants should be at high risk of cardiovascular issues post-revascularization.

Inclusion Criteria

I am between 50 and 85 years old.

I have severe leg pain when walking and very poor blood flow in my legs.

The patient or legal representative will provide informed written consent

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Exclusion Criteria

I do not have severe heart failure that limits my daily activities.

I have not had a heart attack or stroke in the last 3 months.

Presence of a pacemaker

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Treatment Details

Interventions

Coronary computed topography (CT) angiography with FFR-CT (Diagnostic Test)

Trial OverviewThe study is testing the use of coronary CT angiography combined with FFR-CT, a non-invasive imaging technique, to develop a management strategy aimed at improving cardiovascular outcomes in patients with severe PAD after leg revascularization.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Investigational Treatment StrategyExperimental Treatment1 Intervention

This arm will have a coronary CTA with FFR-CT with selective coronary artery revascularization plus optimal medical therapy after lower extremity revascularization

Group II: StandardActive Control1 Intervention

This arm will have optimal medical therapy after lower extremity revascularization