Outcomes of Endovascular Therapy for Lower Limb Artery Diseases
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)
Yonsei University · NCT02748226
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 |
|---|---|
| Enrollment | 12000 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | Yonsei University (other) |
| Locations | 1 site (Seoul) |
| Trial ID | NCT02748226 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Other studies have shown success with similar observational approaches in evaluating endovascular treatments for PAD, indicating that this methodology is well-established.
Eligibility criteria
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 this trial is running
Seoul
- Severance Hospital — Seoul, South Korea (RECRUITING)
Study contacts
- Study coordinator: Young-Guk Ko, PhD
- Email: ygko@yuhs.ac
- Phone: 02)-2228-8460
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Peripheral Arterial Disease