Status:
COMPLETED
Sirolimus-eluting Stents With Biodegradable Polymer Versus an Everolimus-eluting Stents
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Collaborating Sponsors:
Biotronik AG
University of Bern
Conditions:
Coronary Artery Disease
Angina Pectoris
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Coronary artery stents have improved the safety and efficacy of percutaneous coronary intervention for coronary artery disease. Drug-eluting stents have been shown to decrease neointimal hyperplasia a...
Detailed Description
Background Coronary artery stents have improved the safety and efficacy of percutaneous coronary interventions compared with balloon angioplasty alone (New Engl J Med 1994; 331:489-495). Notwithstand...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Age ≥18 years
- Symptomatic coronary artery disease including patients with chronic stable angina, silent ischemia, and acute coronary syndromes including NSTE-ACS and STE-ACS
- Presence of one or more coronary artery stenoses \>50% in a native coronary artery or a saphenous bypass graft which can be treated with a stent ranging in diameter from 2.25 to 4.0 mm and can be covered with one or multiple stents
- No limitation on the number of treated lesions, and vessels, and lesion length
- Exclusion Criteria
- Pregnancy
- Known intolerance to aspirin, clopidogrel, heparin, stainless steel, Sirolimus, Everolimus or contrast material
- Inability to provide informed consent
- Currently participating in another trial before reaching first endpoint
- Planned surgery within 6 months of PCI unless dual antiplatelet therapy is maintained throughout the peri-surgical period
Exclusion
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2018
Estimated Enrollment :
2119 Patients enrolled
Trial Details
Trial ID
NCT01443104
Start Date
February 1 2012
End Date
June 1 2018
Last Update
October 18 2018
Active Locations (9)
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1
Kantonsspital Aarau
Aarau, Switzerland, 5000
2
Universitätsklinik Basel
Basel, Switzerland, 4031
3
Department of Cardiology, Bern University Hospital
Bern, Switzerland, 3010
4
HFR Freiburg
Fribourg, Switzerland, 1708