450 Participants Needed

CT Angiography for Peripheral Arterial Disease

(CAD in sPAD Trial)

Recruiting at 6 trial locations
CQ
Overseen ByClay Quint, MD PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: VA Office of Research and Development
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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 data supports the effectiveness of the treatment Coronary computed tomography (CT) angiography with FFR-CT for Peripheral Arterial Disease?

Research shows that CT angiography with FFR-CT is effective in assessing coronary artery disease by providing detailed images and functional information, helping doctors make better treatment decisions. This suggests it could be useful for evaluating other artery-related conditions like Peripheral Arterial Disease.12345

Is CT angiography generally safe for humans?

CT angiography is generally considered safe, but it does involve exposure to ionizing radiation and iodinated contrast, which can be a concern for some people. Newer techniques have reduced these risks by lowering radiation doses and contrast amounts.678910

How is CT angiography with FFR-CT different from other treatments for peripheral arterial disease?

CT angiography with FFR-CT is unique because it uses advanced imaging technology to provide detailed pictures of blood vessels, helping doctors plan and monitor treatments for peripheral arterial disease. This approach is faster and offers better image quality compared to traditional methods, making it a valuable tool for diagnosing and planning endovascular procedures.611121314

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.

Research Team

CQ

Clay Quint, MD PhD

Principal Investigator

Rocky Mountain Regional VA Medical Center, Aurora, CO

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
See 4 more

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
See 9 more

Timeline

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

Treatment Details

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.
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

Find a Clinic Near You

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials
1,691
Recruited
3,759,000+

References

Integrating CT Myocardial Perfusion and CT-FFR in the Work-Up of Coronary Artery Disease. [2019]
[To promote actively clinical application of advanced cardiovascular CT imaging]. [2021]
[Coronary CT angiography derived fractional flow reserve: view from radiologist]. [2022]
The use of lesion-specific calcium morphology to guide the appropriate use of dynamic CT myocardial perfusion imaging and CT fractional flow reserve. [2022]
[Value of fractional flow reserve derived from coronary computed tomographic angiography and plaque quantitative analysis in predicting adverse outcomes of non-obstructive coronary heart disease]. [2023]
CT Angiography in Patients with Peripheral Arterial Disease: Effect of Small Focal Spot Imaging and Iterative Model Reconstruction on the Image Quality. [2018]
Comparison of standard- and low-tube voltage MDCT angiography in patients with peripheral arterial disease. [2021]
A BMI-adjusted ultra-low-dose CT angiography protocol for the peripheral arteries-Image quality, diagnostic accuracy and radiation exposure. [2018]
Advances in axial imaging of peripheral vascular disease. [2018]
10.United Statespubmed.ncbi.nlm.nih.gov
Aortic calcification index predicts mortality and cardiovascular events in operatively treated patients with peripheral artery disease: A prospective PURE ASO cohort follow-up study. [2022]
[CT-angiography of peripheral arterial diseases: principle and current indications]. [2016]
12.United Statespubmed.ncbi.nlm.nih.gov
Impact of CT angiography on endovascular therapy. [2016]
13.United Statespubmed.ncbi.nlm.nih.gov
Lower extremity computed tomography angiography can help predict technical success of endovascular revascularization in the superficial femoral and popliteal artery. [2018]
14.United Statespubmed.ncbi.nlm.nih.gov
Multidetector CT angiography of peripheral vascular disease: a prospective comparison with intraarterial digital subtraction angiography. [2022]
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