NCT01472718

Thromboaspiration in Patients With High Thrombotic Burden Undergoing Primary Percutaneous Coronary Intervention (PCI)

Efficacy of Thromboaspiration in Patients With High Thrombotic Burden Undergoing Primary Percutaneous Coronary Intervention

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 208 (actual)
• Sponsor: University of Pisa · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

200 consecutive patients presenting with STEMI within 12 hours from the onset of symptoms and having a high thrombotic burden at coronary angiography, defined as the presence of a thrombus size ≥ 2 times the diameter of the vessel, according to a visual estimate. The main objective of the study is to evaluate the effectiveness of thrombectomy (either rheolytic or manual aspiration) as an adjunct to primary or rescue angioplasty, in patients with angiographic evidence high thrombotic burden in the culprit artery. Primary end points: (1) rate of complete ST-segment elevation resolution at 60 minutes after the end of the procedure; (2) infarct size as assessed by delayed-enhancement cardiac magnetic resonance imaging (DE-MRI) at 3 months after the index procedure. Secondary endpoints: post-procedural TIMI flow grade; post-procedural MBG; infarct transmurality at 3 months; MVO at 3 months; 1-year actuarial freedom from MACEs.

Conditions

• Primary PCI for STEMI

Interventions

Type	Name	Description
DEVICE	coronary thrombectomy	coronary thrombectomy with either Angiojet device (rhelytic thrombectomy) or Export device (manual aspiration)
DEVICE	standard primary PCI (with stenting, as required)	standard primary PCI (usually with stenting) for STEMI, without use of thrombectomy or distal protection devices

Timeline

• Start date: 2009-02-01
• Primary completion: 2011-09-01
• Completion: 2012-03-01
• First posted: 2011-11-16
• Last updated: 2019-02-12
• Results posted: 2019-02-12