Actively Recruiting
Coronary Aspiration Catheter Clinical Trial
Led by BrosMed Medical Co., Ltd · Updated on 2025-04-30
144
Participants Needed
1
Research Sites
70 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To evaluation of the efficacy and safety of an aspiration catheter in patients undergoing PCI for acute ST-segment elevation myocardial infarction (STEMI).
CONDITIONS
Official Title
Coronary Aspiration Catheter Clinical Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 80 years old
- Diagnosed with acute ST-segment elevation myocardial infarction (STEMI) within 24 hours of symptom onset
- Voluntarily agree to participate and sign informed consent
- Imaging shows target lesion in coronary artery
- Target vessel has TIMI thrombus load grade 3 or higher and TIMI flow grade 1 or lower
You will not qualify if you...
- Previous PCI or coronary artery bypass grafting in the target vessel
- Cardiogenic shock
- Severe kidney failure or on dialysis
- Severe blood clotting disorders
- Failed preoperative thrombolysis requiring remedial PCI
- Serious bleeding needing transfusion within 30 days before surgery
- Ischemic stroke within 3 months before surgery
- Known allergy to anticoagulant, antiplatelet agents, or contrast media
- Pregnancy or lactation
- Participation or planned participation in other clinical drug or device studies
- Other conditions considered unsuitable by the investigator
- Prognostic aspiration catheter cannot pass original stent mesh to thrombus site
- Severe vessel calcification, tortuosity, or extreme angulation blocking catheter
- Presence of unprotected left main lesion with more than 50% narrowing
- Severe triple coronary artery lesions needing revascularization
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200000
Actively Recruiting
Research Team
G
Ge Junpo, Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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