Coronary Aspiration Catheter Clinical Trial

Korábbi kezelés

• previous PCI intervention or coronary artery bypass grafting (CABG) in the target vessel;
• Serious bleeding events requiring transfusion therapy within 30 days prior to surgery;
• Ischemic stroke within 3 months prior to surgery;
• Participation or planned participation in other clinical studies of drugs or devices;

Más betegség

• severe renal failure or ongoing dialysis;
• severe coagulation abnormalities (e.g., hypercoagulability due to blood disorders);
• Failure of preoperative thrombolysis requiring remedial PCI;
• Known allergy to anticoagulant and antiplatelet agents or contrast media;
• other conditions that the investigator evaluates to be unsuitable for participation in this trial.
  • Imaging exclusion criteria

Egyéb

• General exclusion criteria
• Comorbid cardiogenic shock;
• female subjects who are known to be pregnant or lactating;
• 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.

• 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;