Status:
COMPLETED
Drug-eluting Balloon in Acute Myocardial Infarction
Lead Sponsor:
UMC Utrecht
Conditions:
Coronary Artery Disease
Atherosclerosis
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
PHASE3
Brief Summary
The investigators hypothesize that patients with Acute ST Elevation Myocardial Infarction may benefit from primary angioplasty with use of a drug eluting balloon/bare metal stent combination without i...
Eligibility Criteria
Inclusion
- STEMI within 12 hours of onset of complaints
- Candidate for primary PCI with stent-implantation
- Successful thrombus aspiration defined by no angiographic signs of thrombus a the site of plaque rupture and TIMI flow more or equal 1
Exclusion
- Unable to give written informed consent
- Diabetes and Type C- coronary lesion
- Previous PCI or CABG of infarct related vessel
- Left main stenosis more than 50%.
- Triple vessel disease with stenosis more than 50% in 3 epicardial coronary arteries
- Target vessel reference diameter less than 2.5 and more than 4.0 mm
- Target lesion length more than 25 mm
- Intolerance for aspirin or clopidogrel
- Life expectancy less than 12 months
- Women with child bearing potential
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2016
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00856765
Start Date
March 1 2009
End Date
November 1 2016
Last Update
May 2 2017
Active Locations (2)
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1
University of Modena, Department of Cardiology
Modena, Italy
2
UMC Utrecht
Utrecht, Netherlands, 3584 cx