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

NCT02752100 | Unknown DMC

• 1 other identifier: EILRF
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

PAD

Keywords

Lower Extremity Arterial Occlusive Disease; Interventional Therapy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (10)

• 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)

Study Arms (2)

Interventional Therapy

EXPERIMENTAL

Percutaneous transluminal angioplasty.

Procedure: Percutaneous transluminal angioplasty

Non-Interventional Therapy

NO INTERVENTION

Interventions

Percutaneous transluminal angioplasty PROCEDURE

Interventional Therapy

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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.

Sponsors & Collaborators

• Third Military Medical University: lead

Study Sites (1)

The third hospital affiliated to the Third Military Medical University

Chongqing, 400042, China

RECRUITING

Related Publications (1)

• Zhang Q, Liu X, Li Q, Liu Y, He H, Wang K, Yan Z. Quantitative model for assessment of lower-extremity perfusion in patients with diabetes. Med Phys. 2023 May;50(5):3019-3026. doi: 10.1002/mp.16214. Epub 2023 Jan 16.

  PMID: 36617729 DERIVED

MeSH Terms

Interventions

Angioplasty

Intervention Hierarchy (Ancestors)

Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Central Study Contacts

Yan Zhencheng, MD

CONTACT

86-023-68757882; zhenchengyan@sina.com

Zhu Zhiming, MD, PhD

CONTACT

86-23-68767881; zhuzm@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: March 17, 2016
• First Posted: April 26, 2016
• Study Start: March 1, 2016
• Primary Completion: February 1, 2020
• Study Completion: May 1, 2020
• Last Updated: April 26, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)