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)

Condition(s) studied

Investigational drug(s) / intervention(s)

endovascular treatment: endovascular treatment

Study summary

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.

Eligibility

Primary outcome measure(s)

• Primary patency — 12 months
  Primary patency is defined as freedom from more than 50% restenosis based on CT angiography, duplex ultrasound or catheter-based angiography or from clinically-driven target lesion revascularization.

Trial sites (1)

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