Coronary Aspiration Catheter Clinical Trial

Официальное название

A Prospective, Multicenter, Randomized Controlled, Noninferiority Clinical Trial Evaluating the Efficacy and Safety of an Aspiration Catheter in Patients Undergoing PCI for Acute ST-Segment Elevation Myocardial Infarction (STEMI)

Обзор

To evaluation of the efficacy and safety of an aspiration catheter in patients undergoing PCI for acute ST-segment elevation myocardial infarction (STEMI).

Вмешательства

• Устройство Aspiration Catheter
  Thrombus aspiration using Aspiration Catheter
• Устройство Export Advance Aspiration Catheter
  Thrombus aspiration using Export Advance Aspiration Catheter

Первичные конечные точки

• The rate of TIMI flow grad 3 after PCI [Срок оценки: Immediately after procedure]

Вторичные конечные точки (8)

• TIMI flow after PCI [Срок оценки: Immediately after procedure]
• MBG [Срок оценки: Immediately after procedure]
• TIMI Thrombus Grade [Срок оценки: Immediately after procedure]
• STR(ST-segment resolution) at 90 minutes [Срок оценки: Day 0]
• Thrombus aspiration time and number of aspirations [Срок оценки: Immediately after procedure]
• Device technical success rate [Срок оценки: Immediately after procedure]
• MACE [Срок оценки: 30-day follow-up after procedure]
• AE and SAE [Срок оценки: 30-day follow-up after procedure]

Критерии участия

Критерии включения

\- General inclusion criteria

• Age 18-80 years old (inclusive);
• Clinical diagnosis of acute ST-segment elevation myocardial infarction (STEMI) within 24 hours of the onset of the disease (where ST-segment elevation is defined as ST-segment elevation of ≥1mm or 0.1mV in 2 or more consecutive leads of the 12-lead ECG);
• Voluntary participation and signed written informed consent. Imaging Inclusion Criteria
• DSA image showed that the target lesion was in situ coronary artery lesion;
• Target vessel TIMI thrombus load classification ≥ grade 3 and TIMI flow classification ≤ grade 1;

Критерии исключения

\- General exclusion criteria

• previous PCI intervention or coronary artery bypass grafting (CABG) in the target vessel;
• Comorbid cardiogenic shock;
• severe renal failure or ongoing dialysis;
• severe coagulation abnormalities (e.g., hypercoagulability due to blood disorders);
• Failure of preoperative thrombolysis requiring remedial PCI;
• Serious bleeding events requiring transfusion therapy within 30 days prior to surgery;
• Ischemic stroke within 3 months prior to surgery;
• Known allergy to anticoagulant and antiplatelet agents or contrast media;
• female subjects who are known to be pregnant or lactating;
• Participation or planned participation in other clinical studies of drugs or devices;
• other conditions that the investigator evaluates to be unsuitable for participation in this trial.

Imaging exclusion criteria

• Prognostic aspiration catheter needs to pass through the original stent mesh to reach the thrombus aspiration site;
• severe calcification or tortuosity of the target vessel or extreme angulation that would interfere with the passage of the suction catheter;
• the presence of an unprotected left main lesion (more than 50% narrowing of the lumen diameter);
• the presence of severe triple coronary artery lesions requiring revascularization.

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

Тройное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Zhongshan Hospital, Fudan University — Шанхай

Идентификаторы

NCT: NCT06951724 · D23

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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