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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-01

Study Completion Date

2024-11-01

Brief Summary

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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.

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Detailed Description

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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

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Peripheral Artery Disease Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This will be a parallel interventional model to assign participants to a treatment strategy in a clinical study

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Investigational Treatment Strategy

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

Group Type EXPERIMENTAL

Coronary computed topography (CT) angiography with FFR-CT

Intervention Type DIAGNOSTIC_TEST

The investigational treatment strategy will have a coronary CT angiography diagnostic imaging with computational analysis FFR-CT (Fractional Flow Reserve from the coronary CTA)

Standard

This arm will have optimal medical therapy after lower extremity revascularization

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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)

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Male or female 50 to 85
* Severe intermittent claudication with ABI \< 0.6 or monophasic waveform if non-compressible and TBI \< 0.6
* Chronic limb threatening ischemia (CLTI) with pain at rest (Rutherford Category 4) with ABI \< 0.5 or TBI \< 0.6
* CLTI with minor tissue loss (Rutherford Category 5) with ABI \< 0.5 or TBI \< 0.6
* Completed Lower Extremity Revascularization and enrolled within 45 days
* The patient or legal representative will provide informed written consent
* The patient has a life expectancy of at least 1 year

Exclusion Criteria

* Major tissue loss of the ischemic limb (Rutherford Category 6)
* Uncompensated congestive heart failure (NYHA class IV)
* Myocardial infarction or stroke within the past 90 days
* Prior coronary artery bypass graft (CABG) revascularization surgery
* Prior percutaneous coronary intervention (PCI) with angioplasty or stenting
* Presence of a pacemaker
* Congestive heart failure with Ejection Fraction \< 30%
* Elevated liver function tests more than twice the upper limit of normal
* Severe Chronic renal disease (Glomerular Filtration Rate, GFR \< 30) or on hemodialysis
* Pregnancy, Human Immunodeficiency Virus, or organ transplant recipients
* Current malignancy or malignancy within the last two years unless the treating oncologic physician provides prognosis of an anticipated 2- year survival (i.e., adequately treated non-melanoma skin cancer or adequately treated prostate cancer without metastatic disease)
* Any condition the review panel determines would make the patient unsuitable for participation in the study

Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No