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Идёт набор NCT06124768

Comparison Of Percutaneous Mechanical Thrombectomy With Different Access in Treatment of Acute Deep Venous Thrombosis

— Наблюдательное Deep Vein Thrombosis

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: Percutaneous mechanical thrombectomy (PMT) by the modified approach, Percutaneous mechanical thrombectomy (PMT) by the traditional approach, Traditional approach.
Кому может быть актуально
Состояния в реестре: Deep Vein Thrombosis. Базовые параметры: 18 лет — 85 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
Китай
Следующий шаг
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Официальное название

Comparison Of Percutaneous Mechanical Thrombectomy With Different Access in Treatment of Acute Deep Venous Thrombosis (The CODA Study)

Обзор

The study aims to compare the modified approach through ipsilateral deep calf venous access or contralateral femoral venous access with the traditional approach through ipsilateral popliteal venous access for iliofemoral deep venous thrombosis (DVT) with distal popliteal vein thrombosis, and determine whether it can achieve similar therapeutic effects as iliofemoral DVT without distal popliteal vein thrombosis.

Подробное описание

Acute deep venous thrombosis (DVT) is associated with development of post-thrombotic syndrome (PTS). Early removal of iliofemoral thrombosis by percutaneous mechanical thrombectomy (PMT) may reduce the incidence of PTS. In general, PMT is performed through ipsilateral popliteal venous access as a traditional approach. However, the thrombosis in distal popliteal vein cannot be removed. Previous study demonstrated that the residual thrombus may decrease the efficacy of PMT. The study aims to compare the modified approach through ipsilateral deep calf venous access or contralateral femoral venous access with the traditional approach for iliofemoral DVT with distal popliteal vein thrombosis, and determine whether it can achieve similar therapeutic effects as iliofemoral DVT without distal popliteal vein thrombosis. The purpose of this study is to obtain high-level evidence for the endovascular treatment of acute DVT.

Вмешательства

  • Процедура Percutaneous mechanical thrombectomy (PMT) by the modified approach
    The modified approach includes the ipsilateral calf venous access and the contralateral femoral venous access. Through contralateral femoral venous access, a hydrophilic guide wire and a catheter will be crossover through the thrombus side to the distal calf vein. The ipsilateral calf venous access will be punctured under the guidance of ascending venography. A hydrophilic guide wire and a catheter will be used to pass through the thrombus antegrade to the inferior vena cava. Percutaneous mechan
  • Процедура Percutaneous mechanical thrombectomy (PMT) by the traditional approach
    The traditional approach will be punctured from the ipsilateral popliteal vein under ultrasound guidance. A hydrophilic guide wire and a catheter will be used to pass through the thrombus antegrade to the inferior vena cava. Percutaneous mechanical thrombectomy (PMT) catheter will be used to clear the thrombus. After PMT treatment, residual thrombus will be reevaluated by ascending venography. Catheter-directed thrombolysis (CDT) will be conducted if there is residual thrombus. Percutaneous ball
  • Процедура Traditional approach
    The approach will be punctured from either the ipsilateral femoral vein or popliteal vein. A hydrophilic guide wire and a catheter will be used to pass through the thrombus antegrade to the inferior vena cava. Percutaneous mechanical thrombectomy (PMT) catheter will be used to clear the thrombus. After PMT treatment, residual thrombus will be reevaluated by ascending venography. Catheter-directed thrombolysis (CDT) will be conducted if there is residual thrombus. Percutaneous balloon angioplasty

Первичные конечные точки

  • Incidence of post-thrombotic syndrome [Срок оценки: 24-month]
Вторичные конечные точки (6)
  • Rate of catheter-directed thrombolysis [Срок оценки: Immediately after interventional surgery]
  • Total time of interventional surgery [Срок оценки: Immediately after interventional surgery]
  • Total dosage of urokinase [Срок оценки: Immediately after interventional surgery]
  • Patency rate of lower limb vein [Срок оценки: 24-month]
  • Incidence of post-thrombotic syndrome [Срок оценки: 12-month]
  • Re-intervention rate [Срок оценки: 24-month]

Критерии участия

Критерии включения

  • Age between 18-85 years old;
  • Acute DVT occurred no more than 14 days since the onset of disease;
  • DVT treated by percutaneous mechanical thrombectomy
  • Informed consent signed by patients.

Критерии исключения

  • Patients who are known to be allergic to heparin, low molecular weight heparin, or contrast agent;
  • Women during pregnancy and lactation;
  • Patients with other diseases that may cause difficulty in the study or significantly shorten the life expectancy of patients (<6 months);
  • Patients who are unable or unwilling to participate in the study.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 1 центр
  • Renji Hospital — Шанхай

Идентификаторы

NCT: NCT06124768 · The CODA study

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗