Phase 4
N=126
Distal Protection Device in ST-elevation Myocardial Infarction (STEMI)
ST-segment Elevation Myocardial Infarction
Bottom Line
View on ClinicalTrials.gov: NCT01384019 ↗Enrolled (actual)
126
Serious AEs
11.1%
Results posted
Mar 2013
Primary outcome: Primary: Postinfarct Remodeling — 11; 6 Number of participants with remodeling
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- distal protection and thrombus aspiration (The GuardWire Plus (Medtronic Inc.)) (Device); c-PCI (Procedure)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- Seoul National University Bundang Hospital
- Primary completion
- Jun 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Postinfarct Remodeling |
11; 6 | — |
| SECONDARY Reperfusion Success |
— | — |
Summary
The investigators examined the mechanism underlying the lack of benefit from distal protection and thrombus aspiration (DP-TA) in 126 patients with ST-elevation Myocardial Infarction (STEMI) in a prospective, randomized trial.
Eligibility Criteria
Inclusion Criteria
- 30 and less than 80 years presenting with STEMI
- more than 30 minutes but less than 12 hours after symptom onset
- with ≥ 2 mm of ST-segment elevation in 2 or more contiguous leads or with a presumably new left bundle-branch block
- for whom primary PCI was intended
Exclusion Criteria
- included thrombolytic therapy before PCI;
- spontaneous restoration of coronary flow (> TIMI grade II or III);
- cardiogenic shock (Killip class IV);
- major surgery or active bleeding within 6 weeks;
- aspirin, thienopyridine, or heparin allergy;
- neutropenia ( 2.5 mg/dL [221 μmol/L]);
- noncardiac condition with expected survival less than 1 year;
- current participation in other investigations.
Data sourced from ClinicalTrials.gov (NCT01384019). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.