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Heart risk study for leg artery patients pulled before start

NCT ID NCT06387355

Knowledge-focused Sponsor: VA Office of Research and Development Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled This study
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study was designed to find better ways to manage heart disease in veterans with severe peripheral artery disease (poor leg blood flow) who had leg surgery. It planned to track major heart problems like heart attacks or heart-related death. However, the study was withdrawn before any participants were enrolled, so no results are available.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Started

Nov 2024

Finished

Nov 2024

Lead sponsor

A government agency

The lead sponsor is a US federal agency other than the NIH.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

coronary artery disorder peripheral arterial disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Coronary artery disease Peripheral artery disease

Contacts and locations

Locations

  • Louis Stokes VA Medical Center, Cleveland, OH

    Cleveland, Ohio, 44106-1702, United States

  • North Florida/South Georgia Veterans Health System, Gainesville, FL

    Gainesville, Florida, 32608-1135, United States

  • Rocky Mountain Regional VA Medical Center, Aurora, CO

    Aurora, Colorado, 80045-7211, United States

  • Tennessee Valley Healthcare System Nashville Campus, Nashville, TN

    Nashville, Tennessee, 37212-2637, United States

  • VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

    Dallas, Texas, 75216-7167, United States

  • VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

    Pittsburgh, Pennsylvania, 15240, United States

  • VA Puget Sound Health Care System Seattle Division, Seattle, WA

    Seattle, Washington, 98108-1532, United States

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