Thrombectomy Clinical Trials

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Percutaneous Coronary Intervention With or Without Manual Thrombus Aspiration in Patients With ST-Segment Elevation Myocardial Infarction and Angiographically Evident Thrombus

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this clinical trial is to determine whether manually removing a visible blood clot before percutaneous coronary intervention (PCI) improves outcomes in patients with ST-segment elevation myocardial infarction (STEMI). About 3500 patients who present within 24 hours of symptom onset and have angiographically evident thrombus in the culprit coronary artery (TIMI thrombus grade 2 or higher) will be randomly assigned in a 1:1 ratio to manual thrombus aspiration followed by PCI or PCI alone. The main question is whether adding manual thrombus aspiration reduces the first major adverse cardiac or cerebrovascular event within 30 days. This composite includes death from any cause, recurrent myocardial infarction, stroke, rehospitalization for heart failure, or clinically indicated target-vessel revascularization. Researchers will also compare coronary and myocardial reperfusion after PCI, individual clinical events, stroke and other safety outcomes, and major adverse cardiac or cerebrovascular events through 6 and 12 months. Participants will receive their assigned PCI strategy and will be followed during the index hospitalization and at 30 days, 6 months, and 12 months.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• Confirmed ST-segment elevation myocardial infarction with symptom onset-to-hospital arrival of 24 hours or less.

• Angiographically evident thrombus in the culprit vessel, defined as TIMI thrombus grade 2 or higher before guidewire crossing or any intervention that could alter thrombus burden.

• Written informed consent obtained from the participant or a legally authorized representative before randomization.

Locations
Other Locations
China
Department of Cardiology, The Second Xiangya Hospital of Central South University
RECRUITING
Changsha
Contact Information
Primary
Shenghua Zhou
zhoushenghua@csu.edu.cn
073185292012
Time Frame
Start Date: 2025-07-09
Estimated Completion Date: 2029-07-30
Participants
Target number of participants: 3500
Treatments
Experimental: Manual Thrombus Aspiration + PCI
Participants undergo manual aspiration of angiographically evident thrombus in the culprit coronary artery using the Sniffer II thrombus aspiration catheter, followed by PCI.
Active_comparator: PCI Alone
Participants undergo PCI without planned thrombus aspiration.
Sponsors
Collaborators: Capital Medical University, The First Affiliated Hospital of Dalian Medical University, First Affiliated Hospital Xi'an Jiaotong University, The General Hospital of Northern Theater Command, Second Xiangya Hospital of Central South University, Second Hospital of Jilin University
Leads: Shenghua Zhou

This content was sourced from clinicaltrials.gov

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