Diagnosis and Treatment of Coronary Artery Disease in Severe Peripheral Artery Disease After Lower Extremity Revascularization
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Enrollment
- 450
- Locations
- 11
- Primary Endpoint
- Major adverse cardiovascular events (MACE)
Study Overview
Brief 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.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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
Intervention: Coronary computed topography (CT) angiography with FFR-CT (Diagnostic Test)
Standard
This arm will have optimal medical therapy after lower extremity revascularization
Outcomes
Primary Outcomes
Major adverse cardiovascular events (MACE)
Time Frame: 2 years
cardiovascular-related death or myocardial infarction
Secondary Outcomes
- Myocardioal infarction(2 years)
- All-cause mortality(2 years)
- Amputation-free survival(2 years)
- Cardiovascular-related death(2 years)