Status:
COMPLETED
Comparison of Biomatrix Versus Gazelle in ST-Elevation Myocardial Infarction (STEMI)
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Collaborating Sponsors:
Swiss National Science Foundation
Conditions:
ST-elevation Myocardial Infarction
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Stent study: Treatment of patients with acute myocardial infarction with drug eluting stents (DES) is effective but there remain concerns regarding the long-term safety and adverse effects on the adj...
Detailed Description
Background Stent Study: A routine invasive strategy using percutaneous coronary intervention (PCI) has been shown to improve survival and freedom from recurrent myocardial infarction compared to a t...
Eligibility Criteria
Inclusion
- Age equal or more than 18 years
- Chest pain \> 10 minutes
- Primary pci
- ST-segment elevation of \> 1 mm in \> 2 contiguous leads, or (presumably new) left bundle branch block, or true posterior MI with ST depression of \> 1 mm in \> 2 contiguous anterior leads
- Presence of at least one acute infarct artery target vessel with one or more coronary artery stenoses in a native coronary artery from 2.25-4 mm in diameter that can be covered with 1-multiple stents
Exclusion
- Female of childbearing potential (age 50 and last menstruation within the last 12 months), who did not underwent tubal ligation, ovariectomy or hysterectomy
- Known intolerance to aspirin, clopidogrel, heparin, stainless steel, biolimus or contrast material
- Inability to provide informed consent
- Currently participating in another trial before reaching first endpoint
- Mechanical complication of acute myocardial infarction
- Acute myocardial infarction secondary to stent thrombosis
- Planned surgery within 6 months of PCI unless dual antiplatelet therapy is maintained throughout the perisurgical period
- Noncardiac comorbid conditions are present with life expectancy 1 year or that may result in protocol malcompliance
- History of bleeding diathesis or known coagulopathy
- Use of Coumadin
- Additional for Imaging Substudy:
- Age \> 90 years
- Hemodynamic instability
- Renal failure
- OCT/IVUS technically not feasible
- Any patient in whom angiography demonstrates the infarct lesion to be at the site of a previously implanted stent
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
1161 Patients enrolled
Trial Details
Trial ID
NCT00962416
Start Date
September 1 2009
End Date
January 1 2016
Last Update
March 30 2016
Active Locations (5)
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1
Department of Cardiology
Bern, Switzerland, 3010
2
Dep. of Cardiology
Geneva, Switzerland, 1211
3
Dep. of Cardiology
Lugano, Switzerland, 6900
4
Dep. of Cardiology
University of Lausanne, Switzerland, 1011