Actively Recruiting
Study Comparing Manual Thrombus Aspiration Versus Standard PCI in Adults with STEMI and High Thrombus Burden
Led by Guangdong Provincial People's Hospital · Updated on 2024-11-18
3838
Participants Needed
50
Research Sites
25 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the use of manual thrombus aspiration TA during primary percutaneous coronary intervention PPCI in patients who have experienced an ST-segment Elevation Myocardial Infarction STEMI with a high thrombus burden. The study aims to determine if including TA can reduce major adverse cardiovascular events such as cardiovascular death, recurrent myocardial infarction, stent thrombosis, target vessel revascularization within 180 days, or stroke within 30 days. This is a prospective, multicenter, open-label, randomized controlled trial. Participants are randomly assigned to one of two groups one receiving upfront manual thrombus aspiration followed by PCI, and the other undergoing PCI without the use of manual thrombus aspiration. The treatment is delivered during the primary PCI procedure within 12 hours of symptom onset. The study compares these two approaches to assess their impact on patient outcomes. Throughout the study, participants will be monitored for major adverse cardiovascular events up to 180 days after treatment, with additional tracking of stroke occurrences up to 30 days and composite adverse cardiocerebrovascular events up to one year. Researchers will collect data on safety and efficacy as part of the follow-up period. The trial is led by Guangdong Provincial Peoples Hospital and does not include blinding, with a planned end date in February 2026.
CONDITIONS
Brief Title
Thrombus Aspiration in STEMI Patients With High Thrombus Burden
Research Team
P
Pengchen He, MD
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