Korean Vascular Intervention Society Multicenter Registry Study on Outcomes of Endovascular Therapy in Lower Limb Artery Diseases (K-VIS ELLA): (A Retrospective & Prospective Observational Study)

Yonsei University

Status: Enrolling

Conditions: Peripheral Arterial Disease(PAD)

Treatments: Procedure: endovascular treatment

Study type: Observational

Funder types: Other

Identifiers

NCT02748226

4-2013-0463

Details and patient eligibility

About

1. Study design: multicenter retrospective and prospective observational study

2. Study Cohort :

   1. Retrospective cohort: This cohort retrospectively enrolls patients with lower extremity artery disease who underwent endovascular treatment from January 2006 to the date of approval by IRB in the participating hospitals. Informed consent was waived by IRB.
   2. Prospective cohort: This cohort prospectively enrolls patients with lower extremity artery disease who undergo endovascular treatment from the date of approval by IRB to July, 2018 in the participating hospitals. Informed consent will be obtained prior to enrollment.

3. Baseline clinical and lesion characteristics, procedural and post-procedural data, clinical outcomes, hemodynamic, and imaging follow-up data are investigated. Primary patency and target lesion revascularization rates of the total cohort and patient subgroups are evaluated. Risk factors of restenosis and target lesion revascularization are determined.

Full description

This is an observational study. The study includes patients who underwent endovascular treatments for lower extremity artery diseases and investigates immediate and late outcomes of the treatments. The investigator does not assign any specific interventions.

Enrollment: 12,000 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Retrospective data Patients who underwent or attempted endovascular treatment for symptomatic peripheral artery disease from January 2006 until IRB approval date

• Prospective data

  1. Age 20 years of older

  2. Patients in the treatment or trying about symptomatic peripheral artery disease from IRB approval date

  3. Symptomatic peripheral artery disease:

     • Intermittent claudication (Rutherford category 1 to 3)
     • Critical limb ischemia (Rutherford category 4 to 6)

Exclusion criteria

1. Pregnant women or women with potential childbearing
2. Moderate Alzheimer's disease, mental illness or neurological disease of more than those who can not understand the purpose of this clinical trials and Methods
3. Life expectancy <1 year due to comorbidity

Trial design

12,000 participants in 2 patient groups

Retrospective cohort

Description:

This cohort retrospectively enrolls patients with lower extremity artery disease who underwent endovascular treatment from January 2006 to the date of approval by IRB in the participating hospitals.

Treatment:

Procedure: endovascular treatment

Prospective cohort

Description:

This cohort prospectively enrolls patients with lower extremity artery disease who undergo endovascular treatment from the date of approval by IRB to July, 2018 in the participating hospitals.

Treatment:

Procedure: endovascular treatment