Coronary Artery Disease Clinical Trial
— DUTCH PEERSOfficial title:
DUrable Polymer-based STent CHallenge of Promus Element Versus ReSolute Integrity (DUTCH PEERS): Randomized Multicenter Trial in All Comers Population Treated Within Eastern NeThErlands-2 (TWENTE-2)
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.
Status | Completed |
Enrollment | 1811 |
Est. completion date | December 2013 |
Est. primary completion date | December 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Minimum age of 18 years; - Coronary artery disease and lesion(s) eligible for treatment with drug eluting stents according to clinical guidelines and/or the operators' judgement; - Patient is willing and able to cooperate with study procedures and required follow-up visits; and patient has been informed and agrees on the participation by signing an EC approved written informed consent. Exclusion Criteria: - Participation in another randomized drug or device study before reaching primary endpoint; - Planned surgery within 6 months of PCI unless dual antiplatelet therapy is maintained throughout the peri-surgical period; - Intolerance to a P2Y12 receptor antagonist that results in the patient's inability to adhere to dual-antiplatelet therapy, or intolerance to aspirin, heparin, or components of the two DES examined; - Known pregnancy; - Life expectancy of less than 1 year. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Netherlands | Medisch Centrum Alkmaar | Alkmaar | |
Netherlands | Hospital Rijnstate | Arnhem | |
Netherlands | Scheper Hospital | Emmen | |
Netherlands | Thoraxcentrum Twente | Enschede |
Lead Sponsor | Collaborator |
---|---|
Cardio Research Enschede BV |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Target vessel failure (TVF): a composite of Cardiac death, Target vessel related Myocardial Infarction and Clinically driven repeated target vessel revascularization | 1 year | Yes |
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