Actively Recruiting
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)
Led by BrosMed Medical Co., Ltd · Updated on 2025-04-30
144
Participants Needed
1
Research Sites
18 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effectiveness and safety of an aspiration catheter device in patients undergoing percutaneous coronary intervention (PCI) for acute ST-segment elevation myocardial infarction (STEMI). This trial aims to compare two types of thrombus aspiration catheters to see how well they perform in restoring blood flow during treatment of STEMI. The study is designed as a prospective, multicenter, randomized controlled trial to evaluate if the new device is not inferior to the control device. Participants will be randomly assigned to receive thrombus aspiration therapy using either the test aspiration catheter or the control Export Advance Aspiration Catheter during their PCI procedure. The intervention involves passing the catheter through the affected coronary artery to remove blood clots. The study includes immediate procedural evaluation and a 30-day follow-up to monitor outcomes and safety. Both groups will undergo similar treatment procedures with different devices. During the study, researchers will assess blood flow restoration immediately after PCI using TIMI flow grade and other related measures such as thrombus grade, ST-segment resolution, and device success rate. Safety will be monitored through adverse event tracking up to 30 days after the procedure. Participants will be involved in follow-up visits to evaluate major adverse cardiac events and overall device performance. The total participation period includes the initial procedure and a 30-day post-procedure observation.
CONDITIONS
Brief Title
Coronary Aspiration Catheter Clinical Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 80 years old (inclusive)
- Clinical diagnosis of acute ST-segment elevation myocardial infarction within 24 hours of symptom onset
- Voluntary participation with signed informed consent
- DSA imaging confirming target lesion in the coronary artery
- Target vessel TIMI thrombus 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
- Presence of cardiogenic shock
- Severe kidney failure or ongoing dialysis
- Severe coagulation disorders
- Failed preoperative thrombolysis requiring PCI
- Serious bleeding requiring transfusion within 30 days before surgery
- Ischemic stroke within 3 months before surgery
- Known allergy to anticoagulants, antiplatelets, or contrast media
- Pregnant or lactating females
- Participation in other clinical drug or device studies
- Other conditions deemed unsuitable by the investigator
- Need for aspiration catheter to pass through an original stent mesh
- Severe vessel calcification, tortuosity, or extreme angulation
- Presence of unprotected left main lesion with >50% narrowing
- Severe triple coronary artery lesions requiring revascularization
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day 0
Participants undergo thrombus aspiration therapy using either the test or control aspiration catheter during PCI for acute STEMI.
1 procedure visit (in-person)
Duration - 30 days after procedure
Participants are monitored for safety and major adverse cardiac events following the procedure.
1 follow-up visit (in-person)
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
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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