Clinical trial 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)
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)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Peripheral Arterial Disease(PAD)
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2016-04-22
Enrollment: 12000
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with lower extremity artery disease

Brief 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 hospitals. Informed consent was waived by IRB.
   2. 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.
3. 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.

Eligibility 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

Primary outcomes:
measure: Primary patency
timeFrame: 12 months
Secondary outcomes:
measure: Target lesion revascularization (TLR)
timeFrame: 12 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References:
citation: Roh 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.
citation: Cha 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.
citation: Lim 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.
citation: Kim 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.