← Back to Search

Diagnostic Test

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

N/A

Waitlist Available

Led By Clay Quint, MD PhD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male or female 50 to 85

Severe intermittent claudication with ABI < 0.6 or monophasic waveform if non-compressible and TBI < 0.6

Must not have

Severe Chronic renal disease (Glomerular Filtration Rate, GFR < 30) or on hemodialysis

Uncompensated congestive heart failure (NYHA class IV)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to improve the outcomes of patients with severe peripheral artery disease in the Veteran population by developing a management strategy following lower leg revascularization procedures. The long-term mortality rate for these patients is

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Coronary CT angiography may cause discomfort due to contrast dye, allergic reactions, and exposure to radiation. The side effects are generally mild but can vary based on individual health conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 50 and 85 years old.

Select...

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

Select...

I have minor tissue loss in my leg and very poor blood flow.

Select...

I have severe leg pain even when resting due to poor blood flow.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My kidney function is very low or I am on dialysis.

Select...

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

Select...

My heart's pumping ability is significantly reduced.

Select...

I have had heart bypass surgery in the past.

Select...

I have had a heart procedure to open blocked arteries.

Select...

I have severe tissue loss in my limb due to poor blood flow.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Major adverse cardiovascular events (MACE)

Secondary study objectives

All-cause mortality

Amputation-free survival

Cardiovascular-related death

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

0 / 10Eligibility criteria met