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Идёт набор 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)

— Наблюдательное Peripheral Arterial Disease(PAD)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: endovascular treatment.
Кому может быть актуально
Состояния в реестре: Peripheral Arterial Disease(PAD). Базовые параметры: от 20 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
South Korea
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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.

Подробное описание

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.

Вмешательства

  • Процедура endovascular treatment
    endovascular treatment

Первичные конечные точки

  • Primary patency [Срок оценки: 12 months]
Вторичные конечные точки (1)
  • Target lesion revascularization (TLR) [Срок оценки: 12 months]

Критерии участия

Критерии включения

  • 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)

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

South Korea · 1 центр
  • Severance Hospital — Seoul

Публикации

  • 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. PMID 41711130
  • 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 39256427
  • 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. PMID 35491481
  • 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. PMID 35257522
  • 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. PMID 34327883
  • 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 p PMID 31285068

Идентификаторы

NCT: NCT02748226 · 4-2013-0463

Первоисточники (государственные реестры)

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