DUrable Polymer-based STent CHallenge of Promus Element Versus ReSolute Integrity in an All Comers Population
NCT01331707 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1811
Last updated 2015-07-28
Summary
The introduction of drug-eluting stents (DES) in the treatment of coronary artery disease has led to a significant reduction in morbidity but there are further demands on DES performance. Such demands are an optimized performance in very challenging coronary lesions; third generation DES were developed in an effort to further improve DES performance in such challenging lesions. Two CE-certified third generation DES (Resolute Integrity and Promus Element stents) are currently available; there are no data that indicate an advantage of one of these DES over the other.
Conditions
- Acute Coronary Syndrome
- Angina Pectoris
- Angina, Unstable
- Myocardial Infarction
- Coronary Artery Disease
- Coronary Stenosis
- Coronary Restenosis
Interventions
- DEVICE
-
Resolute Integrity (Zotarolimus-eluting stent)
Third generation drug-eluting stent
- DEVICE
-
Promus Element (Everolimus-eluting stent)
Third generation drug-eluting stent
Sponsors & Collaborators
-
Foundation of Cardiovascular Research and Education Enschede
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-11-30
- Primary Completion
- 2012-12-31
- Completion
- 2013-12-31
Countries
- Netherlands
Study Locations
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