CT Angiography for Peripheral Arterial Disease

(CAD in sPAD Trial)

No longer recruiting at 6 trial locations

Overseen By Clay Quint, MD PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Congestive heart failure, Stroke, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 2 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve heart health in individuals with severe peripheral artery disease (PAD) following a procedure to restore blood flow to their legs. Researchers seek to determine if using a special type of CT scan, known as coronary computed tomography (CT) angiography with FFR-CT, to examine heart arteries, along with regular medical care, can lead to better outcomes. Participants will receive either the standard treatment or the special CT scan and treatment. Suitable candidates have undergone a leg procedure and experience severe leg pain or tissue loss due to blocked arteries. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance treatment options for PAD.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that coronary CT angiography with FFR-CT is safe for patients with peripheral artery disease?

Previous studies have shown that coronary CT angiography with FFR-CT is safe for patients. Research shows that this method can predict heart problems without invasive tests, meaning no tools are inserted into the body, often reducing risk.

Another study found that using FFR-CT to guide treatments significantly lowered death rates in patients with peripheral artery disease. This suggests that the treatment is not only safe but also effective in improving health outcomes.

Overall, evidence indicates that coronary CT angiography with FFR-CT is well-tolerated and safe for patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about coronary computed tomography angiography (CTA) with FFR-CT for peripheral arterial disease because it offers a more precise way to assess blood flow in the arteries compared to standard methods. Unlike traditional imaging techniques that might require invasive procedures, this approach uses advanced imaging to measure the pressure and flow within the coronary arteries non-invasively. This means doctors can better determine if a patient needs further treatment, potentially reducing unnecessary procedures and focusing on those who would benefit the most. This technique aims to enhance patient outcomes by combining detailed imaging with targeted therapy, promising a more tailored and effective treatment strategy.

What evidence suggests that coronary CT angiography with FFR-CT is effective for peripheral artery disease?

Research has shown that coronary CT angiography with FFR-CT can greatly benefit people with peripheral artery disease (PAD). In this trial, participants in the investigational treatment strategy arm will receive this scan, which studies have demonstrated significantly lowers death rates in PAD patients by guiding treatment decisions. This method helps doctors determine which patients truly need surgery, reducing unnecessary procedures. Another study found that this scan accurately detects blood flow problems, which is crucial for proper treatment. Overall, these findings suggest that this technique effectively manages PAD and improves patient survival. ^{2 3 6 7 8}

Who Is on the Research Team?

Clay Quint, MD PhD

Principal Investigator

Rocky Mountain Regional VA Medical Center, Aurora, CO

Are You a Good Fit for This Trial?

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

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a coronary CTA with FFR-CT and selective coronary artery revascularization plus optimal medical therapy

2 years

Follow-up

Participants are monitored for major adverse cardiovascular events, myocardial infarction, all-cause mortality, and amputation-free survival

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Coronary computed topography (CT) angiography with FFR-CT

Trial Overview 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.

How Is the Trial Designed?

Group I: Investigational Treatment Strategy Experimental Treatment 1 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: Standard Active Control 1 Intervention

This arm will have optimal medical therapy after lower extremity revascularization

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Citations

1. ir.heartflow.com ir.heartflow.com/news-releases/news-release-details/heartflow-announces-revolutionary-five-year-data-demonstrating

Release Details - Investor Relations | Heartflow, Inc. First published evidence: FFRCT-guided diagnosis and treatment drastically reduces mortality in peripheral artery disease (PAD) patients.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11502690/

Non-invasive physiological assessment of coronary artery ... As gatekeeper for invasive coronary angiography (ICA), use of CT-FFR results in a significant reduction of negative ICA procedures and ...

3. ahajournals.org ahajournals.org/doi/10.1161/CIRCULATIONAHA.123.063996

On-Site Computed Tomography–Derived Fractional Flow ... In the FORECAST trial, the overall rate of downstream invasive coronary angiography was 22.3%, but CT-FFR was performed as indicated in only 16% ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1078588423005993

Peripheral Arteries Intra-arterial Fractional Flow Reserve ... This pilot study demonstrates that FFR can objectively measure the functional significance of PAS that compares favourably with visual and DUS based assessments ...

5. jacc.org jacc.org/doi/10.1016/j.jcmg.2015.08.006

Noninvasive Fractional Flow Reserve Derived ... - JACC The most recently performed NXT trial investigated the diagnostic performance of FFRCT in 254 patients and 484 vessels (31). The per-vessel ...

6. ahajournals.org ahajournals.org/doi/10.1161/JAHA.124.037988

Prognostic Significance of Computed Tomography ... CT‐FFR provides strong and incremental prognostic information for predicting long‐term outcomes. The combined models incorporating CT‐FFR exhibit modest ...

7. jacc.org jacc.org/doi/10.1016/j.jacc.2023.08.020

Coronary Computed Tomographic Angiography With ... Atherosclerotic risk factors were common. Coronary CTA revealed coronary plaque in 46 participants (92%). A moderate or greater stenosis (≥50%) ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0167527324013160

Coronary CT angiography instead of invasive ... The study investigates feasibility and outcomes following a diagnostic workup of obstructive coronary artery disease in TAVI-candidates with combined Cardiac ...