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

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

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 Overview

• Status: Unknown
• Conditions: PAD
• Intervention / Treatment: Procedure: Percutaneous transluminal angioplasty

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yan Zhencheng, MD; Phone Number: 86-023-68757882; Email: zhenchengyan@sina.com
• Study Contact Backup: Name: Zhu Zhiming, MD, PhD; Phone Number: 86-23-68767881; Email: zhuzm@yahoo.com

Study Locations

• China
  • Chongqing, China, 400042
    • Recruiting
    • The third hospital affiliated to the Third Military Medical University
    • Contact: Zhiming Zhu, MD, PhD; Phone Number: 86-023-68705094; Email: zhuzm@yahoo.com
    • Principal Investigator: Zhiming Zhu, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventional Therapy; Percutaneous transluminal angioplasty.	Procedure: Percutaneous transluminal angioplasty
No Intervention: Non-Interventional Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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)

Collaborators and Investigators

• Sponsor: Third Military Medical University

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Anticipated): February 1, 2020
• Study Completion (Anticipated): May 1, 2020

Study Registration Dates

• First Submitted: March 17, 2016
• First Submitted That Met QC Criteria: April 21, 2016
• First Posted (Estimate): April 26, 2016

Study Record Updates

• Last Update Posted (Estimate): April 26, 2016
• Last Update Submitted That Met QC Criteria: April 21, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: Interventional Therapy; Lower Extremity Arterial Occlusive Disease
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arterial Occlusive Diseases
• Other Study ID Numbers: EILRF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO