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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2020-05-31

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.

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Detailed Description

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Conditions

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PAD

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Interventional Therapy

Percutaneous transluminal angioplasty.

Group Type EXPERIMENTAL

Percutaneous transluminal angioplasty

Intervention Type PROCEDURE

Non-Interventional Therapy

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Percutaneous transluminal angioplasty

Intervention Type PROCEDURE

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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No