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

September 22, 2025 updated by: VA Office of Research and Development

Diagnosis and Treatment of Coronary Artery Disease in Severe Peripheral Artery Disease After Lower Extremity Revascularization

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045-7211
        • Rocky Mountain Regional VA Medical Center, Aurora, CO
    • Florida
      • Gainesville, Florida, United States, 32608-1135
        • North Florida/South Georgia Veterans Health System, Gainesville, FL
    • Ohio
      • Cleveland, Ohio, United States, 44106-1702
        • Louis Stokes VA Medical Center, Cleveland, OH
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15240
        • VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
    • Tennessee
      • Nashville, Tennessee, United States, 37212-2637
        • Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
    • Texas
      • Dallas, Texas, United States, 75216-7167
        • VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
    • Washington
      • Seattle, Washington, United States, 98108-1532
        • VA Puget Sound Health Care System Seattle Division, Seattle, WA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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
Diagnostic test: 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)
No Intervention: Standard
This arm will have optimal medical therapy after lower extremity revascularization

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Major adverse cardiovascular events (MACE)
Time Frame: 2 years
cardiovascular-related death or myocardial infarction
2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cardiovascular-related death
Time Frame: 2 years
death related to cardiovascular disease (i.e., heart attack)
2 years
Myocardioal infarction
Time Frame: 2 years
heart attack
2 years
All-cause mortality
Time Frame: 2 years
death related to any cause
2 years
Amputation-free survival
Time Frame: 2 years
freedom from major amputation
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
VA Office of Research and Development

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Clay Quint, MD PhD, Rocky Mountain Regional VA Medical Center, Aurora, CO

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 22, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 29, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 26, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 22, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SURG-006-23S

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The overall data will be shared and reported, but not individual participant data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

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Locations

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