Cardiovascular and interventional radiology · 2026
Multi-center Randomized Controlled Trial of Catheter-Directed Mechanical Thrombectomy Versus Systemic Thrombolysis in Patients with Acute Intermediate-to-High-Risk Pulmonary Embolism: Study Protocol.
СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Wang Cheng, Fang Peiliang, Zhou Daibing, Xu Bin, Dai Xixi, Zhang Zhenzhou, Xie Mengshi, Duan Zhiyong, Zhang Liang, Li Yongjun, Zhu Yanhua, Jiang Yi, Qie Liangyi, Shi Hongyu, Feng Jiaxuan, Zhang Wenguang, Jin Xian
Аннотация
PURPOSE: This study aims to compare the efficacy and safety of catheter-directed mechanical thrombectomy using the Tendvia system versus systemic thrombolysis in patients with intermediate-to-high-risk acute pulmonary embolism.
MATERIALS AND METHODS: This is a 1:1 block-randomized, controlled, open-label parallel-group, multi-center, superiority trial. Eligible patients aged 18-75 years, diagnosed with intermediate-to-high-risk acute pulmonary embolism and hemodynamic deterioration, will be included. The main exclusion criteria are unsuitable target vessel criteria; sustained systolic hypotension; severe pulmonary hypertension; hematocrit < 28%; chronic pulmonary hypertension; left bundle branch block; chronic left heart failure; renal dysfunction; coagulopathy; recent cardiothoracic surgery; intracardiac thrombus. The intervention group will undergo catheter-directed thrombectomy using the Tendvia system under fluoroscopic guidance within 4 h of computed tomography pulmonary angiography. The control group will receive standard alteplase infusion. The primary efficacy endpoint is absolute reduction in the right ventricular/left ventricular diameter ratio from baseline to 48 h post-intervention, measured by blinded core-lab computed tomography pulmonary angiography analysis. The primary safety endpoint is the rate of composite major adverse events within 48 h. Secondary endpoints include the proportion of patients achieving a ≥ 50% reduction from baseline in NT-proBNP level at 48 h post-intervention, dyspnea scores, change in pulmonary arterial pressure, 48-h post-procedure clinical deterioration, symptomatic recurrence within 30 days, major access site complications, device-related serious adverse events, length of post-procedure hospital and intensive care unit stay, and change in cardiac biomarkers.
EXPECTED GAIN OF KNOWLEDGE: This trial will provide evidence regarding the use of catheter-directed thrombectomy in intermediate-to-high-risk pulmonary embolism.
TRIAL REGISTRATION: This study was registered in Clinicaltrials.gov on 2025-06-22 (Registration number NCT07032025).
MATERIALS AND METHODS: This is a 1:1 block-randomized, controlled, open-label parallel-group, multi-center, superiority trial. Eligible patients aged 18-75 years, diagnosed with intermediate-to-high-risk acute pulmonary embolism and hemodynamic deterioration, will be included. The main exclusion criteria are unsuitable target vessel criteria; sustained systolic hypotension; severe pulmonary hypertension; hematocrit < 28%; chronic pulmonary hypertension; left bundle branch block; chronic left heart failure; renal dysfunction; coagulopathy; recent cardiothoracic surgery; intracardiac thrombus. The intervention group will undergo catheter-directed thrombectomy using the Tendvia system under fluoroscopic guidance within 4 h of computed tomography pulmonary angiography. The control group will receive standard alteplase infusion. The primary efficacy endpoint is absolute reduction in the right ventricular/left ventricular diameter ratio from baseline to 48 h post-intervention, measured by blinded core-lab computed tomography pulmonary angiography analysis. The primary safety endpoint is the rate of composite major adverse events within 48 h. Secondary endpoints include the proportion of patients achieving a ≥ 50% reduction from baseline in NT-proBNP level at 48 h post-intervention, dyspnea scores, change in pulmonary arterial pressure, 48-h post-procedure clinical deterioration, symptomatic recurrence within 30 days, major access site complications, device-related serious adverse events, length of post-procedure hospital and intensive care unit stay, and change in cardiac biomarkers.
EXPECTED GAIN OF KNOWLEDGE: This trial will provide evidence regarding the use of catheter-directed thrombectomy in intermediate-to-high-risk pulmonary embolism.
TRIAL REGISTRATION: This study was registered in Clinicaltrials.gov on 2025-06-22 (Registration number NCT07032025).
Предметные рубрики MeSH
HumansPulmonary EmbolismThrombectomyThrombolytic TherapyFibrinolytic AgentsMulticenter Studies as TopicAdultEquivalence Trials as TopicMiddle AgedFemaleRandomized Controlled Trials as TopicAcute DiseaseTreatment OutcomeMaleAdolescentAgedComputed Tomography AngiographyYoung AdultTissue Plasminogen Activator