NCT02606435

Thrombus Aspiration in Patients With STEMI

Safety and Efficacy of Thrombus Aspiration in Patients With ST-segment Elevation Myocardial Infarction (STEMI)

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Xijing Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, randomized study with blinded outcome assessment, comparing routine manual thrombus aspiration with no aspiration in patients with acute ST-segment elevation myocardial infarction (STEMI) underwent percutaneous coronary intervention (PCI).

Detailed description

This is a prospective, randomized study with blinded outcome assessment, comparing routine manual thrombus aspiration with no aspiration in patients with acute ST-segment elevation myocardial infarction (STEMI) underwent percutaneous coronary intervention (PCI). Patients who are diagnosed as STEMI and referred for PCI will be enrolled. They will be randomized 1:1 to either manual thrombus aspiration with PCI group or PCI alone group.The primary outcome is the composite of cardiovascular death, recurrent myocardial infarction (MI), cardiogenic shock, stroke, new or worsening NYHA class IV heart failure during 1 year follow-up. The secondary efficacy outcome are stent thrombosis, target vessel revascularization, left ventricular function and quality of life during 1 year follow-up.

Conditions

• ST-segment Elevation Myocardial Infarction

Interventions

Type	Name	Description
PROCEDURE	percutaneous coronary intervention (PCI)	percutaneous coronary intervention (PCI) by stent implantation
DEVICE	thrombus aspiration	thrombus aspiration with export catheter

Timeline

• Start date: 2015-11-01
• Primary completion: 2017-11-01
• Completion: 2017-11-01
• First posted: 2015-11-17
• Last updated: 2015-11-17

Locations

1 site across 1 country: China