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NCT Number: NCT02748226

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)

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.

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Key information

Conditions

Peripheral Arterial Disease(PAD) Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Arterial Disease Peripheral Vascular Diseases Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Age 20 years of older
  • Patients in the treatment or trying about symptomatic peripheral artery disease from IRB approval date
  • Symptomatic peripheral artery disease:
  • Intermittent claudication (Rutherford category 1 to 3)
  • Critical limb ischemia (Rutherford category 4 to 6)

Exclusion criteria

  • Pregnant women or women with potential childbearing
  • 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
  • Life expectancy <1 year due to comorbidity

Treatment and study plan

endovascular treatment

Procedure

endovascular treatment

Primary outcomes

  1. Primary patency

    Time frame: 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.

Secondary outcomes

  1. Target lesion revascularization (TLR)

    Time frame: 12 months

    Any re-intervention within the target lesion due to symptom aggravation or drop of ankle brachial index (ABI) >0.15 when compared to post procedure baseline.

Study contacts

Contact information is provided by the study sponsor or research team.

Young-Guk Ko, PhD

CONTACT

[email protected]

02)-2228-8460

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2013
Primary completion
2032
Study completion
2032
First posted
Apr 22, 2016
Registry last updated
Apr 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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