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 other identifier
observational
12,000
1 country
1
Brief Summary
- 1.Study design: multicenter retrospective and prospective observational study
- 2.Study Cohort :
- 3.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.
- 4.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.
- 5.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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2013
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 30, 2013
CompletedFirst Submitted
Initial submission to the registry
April 5, 2016
CompletedFirst Posted
Study publicly available on registry
April 22, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2032
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2032
April 30, 2025
April 1, 2025
18.8 years
April 5, 2016
April 28, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Primary patency
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.
12 months
Secondary Outcomes (1)
Target lesion revascularization (TLR)
12 months
Study Arms (2)
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.
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.
Interventions
Eligibility Criteria
Patients with lower extremity artery disease
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Severance Hospital
Seoul, 120-752, South Korea
Related Publications (5)
Kim YH, Her AY, Ko YG, Ahn CM, Lee SJ, Hong MK, Yu CW, Lee JH, Lee SW, Youn YJ, Yoon CH, Rha SW, Min PK, Choi SH, Chae IH, Choi D; K-VIS ELLA Investigators. Drug-coated balloon versus drug-eluting stent for femoropopliteal total occlusions: intraluminal versus subintimal approaches. Sci Rep. 2024 Sep 11;14(1):21173. doi: 10.1038/s41598-024-71745-0.
PMID: 39256427DERIVEDRoh JW, Shin S, Ko YG, Son NH, Ahn CM, Min PK, Lee JH, Yoon CH, Yu CW, Lee SW, Lee SR, Choi SH, Chae IH, Choi D. 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. Korean Circ J. 2022 Jul;52(7):529-540. doi: 10.4070/kcj.2021.0390. Epub 2022 Mar 28.
PMID: 35491481DERIVEDCha JJ, Kim JY, Kim H, Ko YG, Choi D, Lee JH, Yoon CH, Chae IH, Yu CW, Lee SW, Lee SR, Choi SH, Koh YS, Min PK; K-VIS (Korean Vascular Intervention Society) investigators. Long-term Clinical Outcomes and Prognostic Factors After Endovascular Treatment in Patients With Chronic Limb Threatening Ischemia. Korean Circ J. 2022 Jun;52(6):429-440. doi: 10.4070/kcj.2021.0342. Epub 2022 Feb 10.
PMID: 35257522DERIVEDLim C, Won H, Ko YG, Lee SJ, Ahn CM, Min PK, Lee JH, Yoon CH, Yu CW, Lee SW, Lee SR, Choi SH, Chae IH, Choi D; K-VIS Investigators. Association between Body Mass Index and Clinical Outcomes of Peripheral Artery Disease after Endovascular Therapy: Data from K-VIS ELLA Registry. Korean Circ J. 2021 Aug;51(8):696-707. doi: 10.4070/kcj.2021.0040.
PMID: 34327883DERIVEDKim J, Park TK, Choi KH, Choi D, Ko YG, Lee JH, Yoon CH, Chae IH, Yu CW, Min PK, Lee SW, Lee SR, Koh YS, Choi SH; Korean Vascular Intervention Society (K-VIS) Endovascular therapy in Lower Limb Artery diseases (ELLA) Registry Investigators. Different association between renal dysfunction and clinical outcomes according to the presence of diabetes in patients undergoing endovascular treatment for peripheral artery disease. J Vasc Surg. 2020 Jan;71(1):132-140.e1. doi: 10.1016/j.jvs.2019.03.071. Epub 2019 Jul 5.
PMID: 31285068DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 5, 2016
First Posted
April 22, 2016
Study Start
September 30, 2013
Primary Completion (Estimated)
July 31, 2032
Study Completion (Estimated)
July 31, 2032
Last Updated
April 30, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share