Trials / Completed
CompletedNCT00257153
Thrombus Aspiration Before Standard Primary Angioplasty Improves Myocardial Reperfusion in Acute Myocardial Infarction.
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 160 (planned)
- Sponsor
- Niguarda Hospital · Academic / Other
- Sex
- All
- Age
- 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Coronary thrombus aspiration catheter |
Timeline
- Start date
- 2004-03-01
- Completion
- 2005-09-01
- First posted
- 2005-11-22
- Last updated
- 2006-12-04
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT00257153. Inclusion in this directory is not an endorsement.