Outcomes of Endovascular Therapy for Lower Limb Artery Diseases
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)
Run by Yonsei University · NCT02748226 · Data updated 2026-11-12
This study looks at how well endovascular treatments work for people with lower limb artery diseases, especially those with peripheral arterial disease, to see what helps improve their long-term outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 20 Years and up |
| Sex | All |
| Enrollment | 12000 (estimated) |
| Sponsor | Yonsei University Academic / other |
| Locations | 1 site (Seoul) |
| Status | Recruiting |
| Started | September 30, 2013 |
| Main results expected | July 31, 2032 |
| Study ends | July 31, 2032 |
| Registry record updated | April 30, 2025 |
| Trial ID | NCT02748226 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 20 years or older with symptomatic peripheral artery disease, including those with intermittent claudication or critical limb ischemia.
✕Probably not a fit
Patients who are pregnant, have severe cognitive impairments, or have a life expectancy of less than one year due to comorbidities may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicenter observational study investigates the outcomes of endovascular treatments for patients with lower extremity artery diseases, specifically focusing on peripheral arterial disease (PAD). It includes both a retrospective cohort of patients treated from January 2006 until the IRB approval date and a prospective cohort of patients treated thereafter. The study evaluates clinical and lesion characteristics, procedural data, and long-term outcomes, including primary patency and revascularization rates. The goal is to identify risk factors associated with restenosis and target lesion revascularization.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness of endovascular therapy for PAD, potentially improving treatment strategies and patient outcomes.
How similar studies have gone: Other studies have shown success with similar observational approaches in evaluating endovascular treatments for PAD, indicating that this methodology is well-established.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
1. Age 20 years of older
2. Patients in the treatment or trying about symptomatic peripheral artery disease from IRB approval date
3. Symptomatic peripheral artery disease:
* Intermittent claudication (Rutherford category 1 to 3)
* Critical limb ischemia (Rutherford category 4 to 6)
Exclusion Criteria:
1. Pregnant women or women with potential childbearing
2. 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
3. Life expectancy \<1 year due to comorbidity
Where it's running
-
Severance Hospital
Seoul, South Korea Recruiting
Study contacts
- Study coordinator: Young-Guk Ko, PhD
- Email: ygko@yuhs.ac
- Phone: 02)-2228-8460
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
SGLT2 inhibitors and vascular complications after lower limb revascularization.
This study will test whether people with peripheral arterial disease who took SGLT2 inhibitors around the time of lower limb revascularization have different rates of major heart or limb problems over the following year compared with those who did not take these drugs.
-
Real-world use of the Rotarex rotational excisional atherectomy device for peripheral arteries
This registry will see if the Rotarex rotational excisional atherectomy device can safely and effectively remove blockages in leg arteries for adults with peripheral arterial disease.
-
IVUS-guided revascularization for leg arteries in CLTI
This study tests whether using intravascular ultrasound (IVUS) during leg artery revascularization helps reduce major limb events and significant re-narrowing in adults with chronic limb-threatening ischemia.
-
Evaluating the Oscar Catheter for Treating Peripheral Arterial Disease
This study is testing a new catheter to see if it can safely help people with blocked arteries in their legs feel better after treatment.
-
Transverse versus longitudinal groin incision for vascular surgery
This compares transverse and longitudinal groin incisions to see if transverse incisions lead to fewer wound problems for people having vascular surgery on the groin.
-
Prevalence of PAD in Patients With Surgically Treated Lumbar Spinal Stenosis
This study tests how common peripheral artery disease is in people who have lumbar spinal stenosis and are being considered for, or have had, surgery.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.