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Идёт набор NCT06051032

Compative Study of PE in Thrombosed AVF After Balloon Thrombectomy Vs. Thromboaspiration.

Без фазы С лечением Pulmonary Embolism and 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: Balloon thrombectomy, Thromboaspiration system.
Кому может быть актуально
Состояния в реестре: Pulmonary Embolism and Thrombosis. Базовые параметры: от 18 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
Испания
Следующий шаг
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Официальное название

Prospective Randomized Comparative Study on the Incidence of Pulmonary Emboembolism (PE) After Endovascular Treatment of Thrombosed Dialysis Arterio Venous Fistulas (AVF): Balloon Thrombectomy Versus Thromboaspiration Systems.

Обзор

The goal of this multicentric clinical trial is to compare the incidence of pulmonary thromboembolism (PTE), assessed through AngioCT, in the endovascular treatment of acute thrombosis in native and prosthetic arteriovenous fistulas (AVF). The main questions it aims to answer are: * What is the difference in the incidence of pulmonary thromboembolism (PTE) assessed by AngioCT in endovascular treatment of acute thrombosis of native and prosthetic arteriovenous fistulas using balloon thrombectomy versus thromboaspiration systems? * What is the primary patency rate of arteriovenous fistulas treated with balloon thrombectomy versus thromboaspiration systems? * What is the clinical success rate in the treatment of arteriovenous fistulas using balloon thrombectomy compared to thromboaspiration systems? * What are the costs associated with the different thrombectomy techniques in the treatment of arteriovenous fistulas? Participants will be underwent to balloon thrombectomy versus thromboaspiration systems. Researchers will compare the patients treated with balloon thrombectomy and thromboaspiration systems to see if the incidence of PE is comparable and to evaluate the primary and secondary patency rates of both thrombectomy techniques, the clinical technical success rate, and the costs associated with each technique.

Вмешательства

  • Устройство Balloon thrombectomy
    A specialized catheter with an inflatable balloon at the tip is inserted over a guidewire, previously inserted through the sheath, and advanced to the location of the clot within the blood vessel. The catheter is positioned precisely using fluoroscopic guidance or other imaging modalities. Once positioned, the balloon is inflated, creating pressure against the clot and effectively removing or dislodging it from the vessel walls.
  • Устройство Thromboaspiration system
    The thromboaspiration catheter is carefully guided to the site of the clot within the blood vessel. Once positioned, the suction mechanism is activated, creating a vacuum effect. The catheter gently aspirates or suctions the clot, gradually removing it from the vessel walls. The procedure is performed under fluoroscopic guidance or other imaging modalities to ensure accurate placement of the catheter and successful clot aspiration.

Первичные конечные точки

  • Incidence of PTE after thrombectomy of native and prosthetic AVFs. [Срок оценки: The presence of PTE will be evaluated within 24 hours after treatment.]
  • PTE resolution rate 1 month after thrombectomy of native and prosthetic AVFs. [Срок оценки: The resolution of PTE will be evaluated 1-month after the treatment]

Критерии участия

Критерии включения

  • Patients with acute thrombosis (< 10 days) of native or prosthetic AVF.

Критерии исключения

  • Known pulmonary hypertension.
  • Severe pulmonary disease.
  • Low cardiopulmonary reserve.
  • Recent creation of vascular access.
  • Known right left shunt.
  • Access infection.
  • Allergy to iodinated contrast.
  • Patients under 18 years old.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

Испания · 1 центр
  • Hospital La Fe — Valencia

Публикации

  • Fonseca AV, Toledo Barros MG, Baptista-Silva JC, Amorim JE, Vasconcelos V. Interventions for thrombosed haemodialysis arteriovenous fistulas and grafts. Cochrane Database Syst Rev. 2024 Feb 14;2(2):CD013293. doi: 10.1002/14651858.CD013293.pub2. PMID 38353936

Идентификаторы

NCT: NCT06051032 · 2022-803-1

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗