Diagnosis and Treatment of CAD in Severe PAD After Lower Extremity Revascularization
Withdrawn before enrolling · Not applicable
Conditions studied: Peripheral Artery Disease, Coronary Artery Disease
In brief
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.
Key facts
- Study ID
- NCT06387355
- Run by
- VA Office of Research and Development
- People needed
- 0
- Starts
- 2024-11-01
- Expected to finish
- 2024-11-01
- Last updated by the study team
- 2025-09-26
Who can join
Age: 50 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Rocky Mountain Regional VA Medical Center, Aurora, CO — Aurora, Colorado, United States
- North Florida/South Georgia Veterans Health System, Gainesville, FL — Gainesville, Florida, United States
- Louis Stokes VA Medical Center, Cleveland, OH — Cleveland, Ohio, United States
- VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA — Pittsburgh, Pennsylvania, United States
- Tennessee Valley Healthcare System Nashville Campus, Nashville, TN — Nashville, Tennessee, United States
- VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX — Dallas, Texas, United States
- VA Puget Sound Health Care System Seattle Division, Seattle, WA — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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