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

T

Third Military Medical University

Status

Unknown

Conditions

PAD

Treatments

Procedure: Percutaneous transluminal angioplasty

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

200 estimated patients

Sex

All

Ages

40 to 90 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

200 participants in 2 patient groups

Interventional Therapy
Experimental group
Description:
Percutaneous transluminal angioplasty.
Treatment:
Procedure: Percutaneous transluminal angioplasty
Non-Interventional Therapy
No Intervention group

Trial contacts and locations

1

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Central trial contact

Yan Zhencheng, MD; Zhu Zhiming, MD, PhD

Data sourced from clinicaltrials.gov

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