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

Third Military Medical University200 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

200

Conditions

PAD

Interventions

Eligibility

Sex: ALLMin age: 40 YearsMax age: 90 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Ankle-brachial index

Time frame: Change from baseline at 1 year(End of Trial)

Mortality(%)

Time frame: 1 year(End of Trial)

Incidence of amputation(%)

Time frame: 1 year(End of Trial)

Secondary Outcomes

Incidence of major adverse cardiac events (MACE)(%)

Time frame: 1 year(End of Trial)

High-sensitive C reactive protein(mg/L)

Time frame: Change from baseline at 1 year(End of Trial)

Fasting plasma glucose(mmol/L)

Time frame: Change from baseline at 1 year(End of Trial)

Blood pressure(mmHg)

Time frame: Change from baseline at 1 year(End of Trial)

HbA1c(%)

Time frame: Change from baseline at 1 year(End of Trial)

triglyceride(mmol/L)

Time frame: Change from baseline at 1 year(End of Trial)

total cholesterol(mmol/L)

Time frame: Change from baseline at 1 year(End of Trial)

LDL-c(mmol/L)

Time frame: Change from baseline at 1 year(End of Trial)

HDL-c(mmol/L)

Time frame: Change from baseline at 1 year(End of Trial)

The lower limb transcutaneous oxygen pressure(mmHg)

Time frame: Change from baseline at 1 year(End of Trial)

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts