Thrombus Aspiration Before Standard Primary Angioplasty Improves Myocardial Reperfusion in Acute Myocardial Infarction.
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.
Acute Myocardial Infarction
Device: Coronary thrombus aspiration catheter
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
- ST-segment resolution immediately after primary angioplasty
- Myocardial Blush grade after angioplasty.
- Coronary TIMI flow grade,
- distal embolization,
- no reflow
|Study Start Date:||March 2004|
|Estimated Study Completion Date:||September 2005|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00257153
|Cardiology department, Niguarda hospital|
|Milan, Italy, 20162|
|Principal Investigator:||Pedro L Silva-Orrego, MD||Interventional cardiology laboratory, Cardiology Dpt, Niguarda Hospital|
|Study Chair:||Riccardo Bigi, MD||Cardiology Dpt. of medicine and surgery, University school of medicine, Milan, Italy|
|Study Director:||Paola Colombo||Cardiology Dpt. Niguarda hospital|
|Study Chair:||Silvio Klugmann, MD||cardiology Dpt. Niguarda hospital.|