Diagnosis and Treatment of CAD in Severe PAD After Lower Extremity Revascularization (NCT06387355) | Clinical Trial Compass
WithdrawnNot Applicable
Diagnosis and Treatment of CAD in Severe PAD After Lower Extremity Revascularization
Stopped: Intent to fund was rescinded
United States0Started 2024-11-01
Plain-language summary
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.
Who can participate
Age range50 Years – 85 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 diseas…