Coronary Aspiration Catheter Clinical Trial
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)
BrosMed Medical Co., Ltd
144 participants
Feb 20, 2025
INTERVENTIONAL
Conditions
Summary
To evaluation of the efficacy and safety of an aspiration catheter in patients undergoing PCI for acute ST-segment elevation myocardial infarction (STEMI).
Eligibility
Inclusion Criteria4
- 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);
- 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;
Exclusion Criteria15
- 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.
- 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.
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Interventions
Thrombus aspiration using Aspiration Catheter
Thrombus aspiration using Export Advance Aspiration Catheter
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06951724