Status:
COMPLETED
Safety and Efficacy Study Comparing 3 New Types of Coronary Stents
Lead Sponsor:
University Hospital, Basel, Switzerland
Conditions:
Coronary Artery Disease
Coronary Thrombosis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Background: Retrospective analyses of long-term BASKET findings identified patients with large drug-eluting stents (DES) (\>2.5mm Stents) as patients at risk for late cardiac death/nonfatal myocardia...
Detailed Description
Background and Study Design The study is a multicentre, prospective, randomized, open-label trial comparing safety and efficacy of the Nobori® drug-eluting stent (DES), the Xience Prime® DES, and the...
Eligibility Criteria
Inclusion
- written informed concent
- need for large (≥3.0 mm stents only) native vessel stenting
Exclusion
- in-Stent Restenosis or in-Stent Thrombosis
- bypass graft disease to be stented
- main stem disease to be stented
- cardiogenic shock by clinical assessment (signs of organ hypoperfusion)
- planned surgery within the next 12 months
- oral anticoagulation needed (artificial heart valves,atrial fibrillation) or chronic haemorrhagic diathesis
- active bleeding disorders
- index-PCI = planned PCI of additional lesion
- no follow-up (FU) expected/possible
- History of stroke or TIA (contraindication for prasugrel)
- known severe hypersensitivity reaction to ASS and/or Prasugrel
- no compliance expected / no informed consent given
- enrolled in another study
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
2291 Patients enrolled
Trial Details
Trial ID
NCT01166685
Start Date
April 1 2010
End Date
May 1 2014
Last Update
June 5 2014
Active Locations (8)
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1
Universitätsklinikum
Innsbruck, Austria, 6020
2
Gentofte Hospital
Hellerup, Denmark, 2900
3
Elisabethen Krankenhaus
Essen, North Rhine-Westphalia, Germany, 45138
4
Kantonsspital
Aarau, Canton of Aargau, Switzerland, 5000