Clinical Trial of Thrombectomy Systems

Официальное название

A Prospective, Multicenter, Single-Arm Clinical Trial Evaluating the Safety and Efficacy of Thrombectomy Systems for the Treatment of Lower Extremity Deep Vein Thrombosis

Обзор

This study plans to enroll 167 subjects. Subject enrollment and treatment details will be documented, and follow-up assessments will be conducted at screening, on the procedure day, before discharge, and at 1, 3, and 6 months after the procedure, to assess the safety and efficacy of the peripheral thrombectomy system for the treatment of lower extremity deep vein thrombosis.

Вмешательства

• Устройство Peripheral thrombectomy system
  For the subjects who met the requirements of the study protocol, the BM peripheral thrombectomy system was used for treatment.

Первичные конечные точки

• Technical success rate [Срок оценки: Immediately after procedure, 0 day]

Вторичные конечные точки (6)

• Major adverse events (MAE) rate [Срок оценки: 30 days]
• Device success rate [Срок оценки: Immediately after procedure, 0 day]
• VCSS score [Срок оценки: Baseline, 1 Month, 6 Months]
• Vein Patency [Срок оценки: at 6 months]
• Incidence of PTS [Срок оценки: at 6 Months]
• AE and SAE [Срок оценки: Up to 6 months]

Критерии участия

Критерии включения

• Age ≥18 years；
• Confirmed lower extremity deep vein thrombosis (DVT) by imaging, meeting at least one of the following: (1) acute iliofemoral or femoropopliteal DVT; or (2) subacute iliofemoral DVT;
• Investigator-assessed life expectancy ≥1 year;
• Willing to participate in this study and provide written informed consent.

Критерии исключения

• Infection at the puncture site or severe systemic infection;
• Inability to establish vascular access or difficulty in advancing the guidewire through the lesion;
• Hemodynamically unstable pulmonary embolism;
• The target lesion thrombosis is recurrent after prior interventional therapy;
• A venous stent has been implanted in the target lesion, or the presence of an inferior vena cava filter that interferes with device deployment;
• Bilateral lower extremity deep vein thrombosis requiring thrombectomy in the same procedure;
• Active bleeding within the past 30 days, including severe intracranial, gastrointestinal, or urinary tract bleeding;
• History of hemorrhagic or ischemic stroke within the past 30 days;
• Known severe coagulation disorder or bleeding tendency;
• Severe hepatic or renal impairment;
• Known allergy or significant hypersensitivity to iodine-based contrast media, thrombolytic agents, anticoagulants, or antiplatelet drugs;
• Known conditions such as severe hyperthyroidism, multiple myeloma, or severe heart failure that preclude tolerance to percutaneous transluminal angioplasty;
• Pregnant or lactating women, or women planning to become pregnant during the study period;
• Currently participating in any other clinical trial of a drug or medical device;
• Any other condition that, in the investigator's judgment, makes the subject ineligible for participation in this trial.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Zhongshan Hospital, Fudan University — Шанхай

Идентификаторы

NCT: NCT07749820 · BM-D21

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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