A Study on the Effects of Interventional Therapy in Patients With Lower Extremity Arterial Occlusive Disease and Its Risk Factors(EILRF)

Study Overview
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Brief Summary
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Along with the improvement of living standard, the prevalence of Lower extremity arterial occlusive disease (LEAOD) is also increasing, which has become an important cause of lower extremity amputation and greatly affected the patients' life quality. Currently, percutaneous transluminal angioplasty (PTA), including balloon dilatation and stent implantation, has been regarded as the most widely applied and accepted treatment for LEAOD. The therapeutic effects of lower extremity interventional treatment, varied in different reports. It was reported that the therapeutic effects were influenced by some traditional risk factors, including age, gender, smoking, and so on. More risk factors are still unknown. The difference of therapeutic effects, the endpoint events were compared between interventional and conventional treatment group to analyze the effect of interventional treatment on LEAOD and explore its risk factors.

Official Title
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Long-term Prognosis of Interventional Therapy in Patients With Lower Extremity Arterial Occlusive Disease and Its Risk Factors

Conditions
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PAD

Intervention / Treatment
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* Procedure: Percutaneous transluminal angioplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, age between 40-90 years old. Ankle-brachial index(ABI)<0.9. Lower extremity arterial CT shows that the arterial stenosis>50% Exclusion Criteria: Type 2 diabetes with acute complications. Type 1 diabetes. Cerebrovascular diseases in the last 3 months. Cardiovascular diseases (myocardial infarction, angina, cardiac failure) in the last 3 months. Hemorrhagic disease. Hypohepatia (AST or AST is twice higher than the upper limit) or cirrhosis, hepatic encephalopathy. History of dialysis. Chronic obstructive pulmonary disease (COPD), chronic respiratory failure or hypoxemia. Acute infections, tumor, severe arrhythmia, mental disorders, alcohol or medicine addiction. Fertile woman without contraceptives. Allergic to iodine. Unable to understanding and follow the study protocol orientations.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventional Therapy<br>Percutaneous transluminal angioplasty. | Procedure: Percutaneous transluminal angioplasty<br> <br> |
| No Intervention: Non-Interventional Therapy<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ankle-brachial index |  | Change from baseline at 1 year(End of Trial) | 
| Mortality(%) |  | 1 year(End of Trial) | 
| Incidence of amputation(%) |  | 1 year(End of Trial) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of major adverse cardiac events (MACE)(%) |  | 1 year(End of Trial) | 
| High-sensitive C reactive protein(mg/L) |  | Change from baseline at 1 year(End of Trial) | 
| Fasting plasma glucose(mmol/L) |  | Change from baseline at 1 year(End of Trial) | 
| Blood pressure(mmHg) |  | Change from baseline at 1 year(End of Trial) | 
| HbA1c(%) |  | Change from baseline at 1 year(End of Trial) | 
| triglyceride(mmol/L) |  | Change from baseline at 1 year(End of Trial) | 
| total cholesterol(mmol/L) |  | Change from baseline at 1 year(End of Trial) | 
| LDL-c(mmol/L) |  | Change from baseline at 1 year(End of Trial) | 
| HDL-c(mmol/L) |  | Change from baseline at 1 year(End of Trial) | 
| The lower limb transcutaneous oxygen pressure(mmHg) |  | Change from baseline at 1 year(End of Trial) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lower Extremity Arterial Occlusive Disease, Interventional Therapy