Peripheral Arterial Disease(PAD)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)
An observational study of Peripheral Arterial Disease(PAD), run by Yonsei University at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Peripheral Arterial Disease(PAD)
- What is being tested?
- endovascular treatment
- Type of treatment
- Surgery or procedure
- How many people
- 12,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Sep 2013to 31 Jul 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with lower extremity artery disease
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Severance Hospital
Seoul, 120-752
Donghoon Choi, 82-2-2228-8460, cdhljy@yuhs.ac
About this study
- Study design: multicenter retrospective and prospective observational study
- Study Cohort :
- 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.
- 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.
- 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.
Read the detailed 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.
- Conditions
- Peripheral Arterial Disease(PAD)
- Being tested
- endovascular treatment
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endovascular treatmentProcedure or surgery
endovascular treatment
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: endovascular treatment | |
| 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. Receives: Procedure: endovascular treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (1)
Target lesion revascularization (TLR)
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2016 (estimated)
- Study start30 Sep 2013
- Primary completion31 Jul 2032 (estimated)
- Study completion31 Jul 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial Disease(PAD)Studies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 12,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02748226
- Sponsor's protocol ID
- 4-2013-0463
- Status last verified
- Apr 2025
- First submitted
- 5 Apr 2016
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jeon BK, Ko YG, Lee SJ, Ahn CM, Lee SH, Lee YJ, Hong SJ, Kim JS, Kim BK, Choi D, Hong MK. Elevated skin perfusion pressure 48 hours after endovascular therapy predicts early wound healing in chronic limb-threatening ischemia. Vasc Med. 2026 Apr;31(2):165-174. doi: 10.1177/1358863X251414636. Epub 2026 Feb 19.
PubMed 41711130Kim 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.
PubMed 39256427Roh 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.
PubMed 35491481Cha 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.
PubMed 35257522Lim 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.
PubMed 34327883Kim 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.
PubMed 31285068
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT02748226
- Acronym / sponsor ID
- 4-2013-0463
- Conditions
- Peripheral Arterial Disease(PAD)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 12,000 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 30 Sep 2013 (actual)
- Primary completion
- 31 Jul 2032 (estimated)
- Study completion
- 31 Jul 2032 (estimated)
- First posted
- 22 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Study design: multicenter retrospective and prospective observational study
- Study Cohort :
- 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.
- 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.
- 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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective cohort | – | Procedure: endovascular treatmentThis 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 | – | Procedure: endovascular treatmentThis 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with lower extremity artery disease
Key inclusion criteria (7 listed)
- Retrospective data Patients who underwent or attempted endovascular treatment for symptomatic peripheral artery disease from January 2006 until IRB approval date
- Prospective data
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| endovascular treatmentendovascular treatment | Procedure or surgery | Prospective cohort, Retrospective cohort |
Primary outcome
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.
1 secondary outcome
Target lesion revascularization (TLR)
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- Derived from this study: PubMed 41711130Jeon BK, Ko YG, Lee SJ, Ahn CM, Lee SH, Lee YJ, Hong SJ, Kim JS, Kim BK, Choi D, Hong MK. Elevated skin perfusion pressure 48 hours after endovascular therapy predicts early wound healing in chronic limb-threatening ischemia. Vasc Med. 2026 Apr;31(2):165-174. doi: 10.1177/1358863X251414636. Epub 2026 Feb 19.
- Derived from this study: PubMed 39256427Kim 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.
- Derived from this study: PubMed 35491481Roh 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.
- Derived from this study: PubMed 35257522Cha 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.
- Derived from this study: PubMed 34327883Lim 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.
- Derived from this study: PubMed 31285068Kim 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Arterial Disease(PAD), run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Young-Guk Ko, PhD (02)-2228-8460, ygko@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary patency (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02748226, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2025.