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Thrombus Aspiration Before Standard Primary Angioplasty Improves Myocardial Reperfusion in Acute Myocardial Infarction.

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00257153
Enrollment
160
Registered
2005-11-22
Start date
2004-03-31
Completion date
2005-09-30
Last updated
2006-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myocardial Infarction

Keywords

Acute myocardial infarction, primary angioplasty, myocardial reperfusion, thrombus aspiration

Brief summary

In patients with acute ST-segment elevation myocardial infarction (STEMI), percutaneous coronary intervention (PCI) may cause thrombus dislodgment and impaired microcirculatory reperfusion. This study was designed to test the hypothesis that thrombus aspiration before standard PCI may improve acute myocardial reperfusion, measured by ST-segment resolution (STR) and myocardial blush grade (MBG), compared with standard PCI.

Detailed description

Consecutive STEMI patients, admitted within 12 hours of symptom onset and scheduled for primary PCI are randomly assigned to two treatment strategies: standard PCI including stenting and abciximab (group1) or thrombus aspiration with Pronto™ extraction catheter (Vasc.solutions, Minneapolis) before standard PCI (group2). Patients with cardiogenic shock, previous infarction or thrombolytic therapy are excluded.

Interventions

DEVICECoronary thrombus aspiration catheter

Sponsors

Niguarda Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 80 Years
Healthy volunteers
No

Inclusion criteria

* ST-segment elevation myocardial infarction patients undergoing primary angioplasty within 12 hours from symptom onset.

Exclusion criteria

* Cardiogenic shock, previous infarction, previous coronary bypass surgery,bundle branch block or pacemaker induced rythm, controindications to IIb/IIIa inhibitors.

Design outcomes

Primary

MeasureTime frame
ST-segment resolution immediately after primary angioplasty
Myocardial Blush grade after angioplasty.

Secondary

MeasureTime frame
Coronary TIMI flow grade,
distal embolization,
no reflow

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 8, 2026