Status:
COMPLETED
Bare Metal Stent Versus Drug Coated Balloon With Provisional Stenting in Non-ST-Elevation Myocardial Infarction
Lead Sponsor:
University Hospital, Saarland
Conditions:
Coronary Heart Disease
NSTEMI
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The aim of the present trial is to assess the efficacy of the standalone use of SeQuent(R) Please coated balloon compared to a bare metal stent (BMS) in patients with NSTEMI.
Detailed Description
The aim of the present trial is to assess the efficacy of the standalone use of SeQuent(R) Please coated balloon compared to a bare metal stent (BMS) in patients with NSTEMI. Primary efficacy endpoint...
Eligibility Criteria
Inclusion
- NSTEMI with
- Ischemic symptoms (angina pectoris) \> 30 minutes
- Last symptoms within 72 hours before randomization
- Positive cardiac troponin T, I, or hs-Troponin above 99th percentile
- age \> 18 years
- Identifiable culprit lesion without angiographic evidence of large thrombus with intended early PCI (treatment of up to two lesions allowed)
Exclusion
- Cardiogenic shock
- ST-elevation myocardial infarction
- No identifiable culprit lesion, Indication for acute bypass surgery
- Comorbidity with limited life expectancy \< 9-12 months
- Contraindication for treatment with heparin, ASA and thienopyridines
Key Trial Info
Start Date :
December 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 23 2022
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT01489449
Start Date
December 1 2012
End Date
June 23 2022
Last Update
May 6 2023
Active Locations (1)
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1
Klinik fuer Innere Medizin III, Universitaetsklinikum des Saarlandes
Homburg/Saar, Saarland, Germany, 66421