Actively Recruiting

Age: 20Years +
All Genders
ID02748226

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

Led by Yonsei University · Updated on 2025-04-30

12000

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying patients with lower extremity artery disease who have undergone or will undergo endovascular treatments. This observational study includes both retrospective and prospective groups to investigate the immediate and long-term results of these treatments. The study aims to understand treatment outcomes such as vessel patency and the need for repeat procedures, as well as risk factors for restenosis and target lesion revascularization. The study consists of two cohorts: a retrospective cohort enrolling patients treated from January 2006 until IRB approval, and a prospective cohort enrolling patients treated from IRB approval until July 2018. No new treatments are assigned by the researchers, as this study observes standard endovascular treatments. Data on clinical characteristics, procedural details, imaging, and follow-up outcomes are collected for all participants. Participants are monitored through clinical and imaging evaluations to assess vessel patency and the occurrence of target lesion revascularization at 12 months. Researchers collect baseline and follow-up information including hemodynamic measurements and clinical outcomes. The total study duration includes retrospective data review and prospective follow-up of patients undergoing treatment, with ongoing assessment of risk factors and treatment effectiveness.

CONDITIONS

Brief Title

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)

Who Can Participate

Age: 20Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients who underwent or attempted endovascular treatment for symptomatic peripheral artery disease from January 2006 until IRB approval date (retrospective cohort)
  • Age 20 years or older (prospective cohort)
  • Patients undergoing or planning endovascular treatment for symptomatic peripheral artery disease from IRB approval date
  • Symptomatic peripheral artery disease defined as intermittent claudication (Rutherford category 1 to 3) or critical limb ischemia (Rutherford category 4 to 6)
Not Eligible

You will not qualify if you...

  • Pregnant women or women who could potentially become pregnant
  • Individuals with moderate Alzheimer's disease, significant mental illness, or neurological disease impairing understanding of the study
  • Life expectancy less than 1 year due to other medical conditions

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - Up to 12 months

Participants who underwent endovascular treatment for lower extremity artery disease are observed to investigate immediate and late outcomes of the treatments.

Visits scheduled according to routine follow-up care up to 12 months

Trial Site Locations

Total: 1 location

1

Severance Hospital

Seoul, South Korea, 120-752

Actively Recruiting

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Research Team

Y

Young-Guk Ko, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Published Research Related To This Trial

Elevated skin perfusion pressure 48 hours after endovascular therapy predicts early wound healing in chronic limb-threatening ischemia.

Bo Kyung Jeon, Young-Guk Ko, Seung-Jun Lee...

https://pubmed.ncbi.nlm.nih.gov/41711130

Drug-coated balloon versus drug-eluting stent for femoropopliteal total occlusions: intraluminal versus subintimal approaches.

Yong Hoon Kim, Ae-Young Her, Young-Guk Ko...

https://pubmed.ncbi.nlm.nih.gov/39256427

Long-Term Clinical Outcomes of Iliac Artery Endovascular Therapy in the Korean Vascular Intervention Society Endovascular Therapy in Lower Limb Artery Diseases (K-VIS ELLA) Registry.

Ji Woong Roh, Sanghoon Shin, Young-Guk Ko...

https://pubmed.ncbi.nlm.nih.gov/35491481

Long-term Clinical Outcomes and Prognostic Factors After Endovascular Treatment in Patients With Chronic Limb Threatening Ischemia.

Jung-Joon Cha, Jong-Youn Kim, Hyoeun Kim...

https://pubmed.ncbi.nlm.nih.gov/35257522

Association between Body Mass Index and Clinical Outcomes of Peripheral Artery Disease after Endovascular Therapy: Data from K-VIS ELLA Registry.

Chewan Lim, Hoyoun Won, Young Guk Ko...

https://pubmed.ncbi.nlm.nih.gov/34327883

Different association between renal dysfunction and clinical outcomes according to the presence of diabetes in patients undergoing endovascular treatment for peripheral artery disease.

Jihoon Kim, Taek Kyu Park, Ki Hong Choi...

https://pubmed.ncbi.nlm.nih.gov/31285068