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Stopped: Intent to fund was rescinded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 range
50 Years – 85 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.