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)
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Acute Coronary Syndrome
- Sponsor
- Foundation of Cardiovascular Research and Education Enschede
- Enrollment
- 1811
- Locations
- 4
- Primary Endpoint
- Target vessel failure (TVF): a composite of Cardiac death, Target vessel related Myocardial Infarction and Clinically driven repeated target vessel revascularization
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief 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.
Investigators
prof. C. von Birgelen
Professor C. von Birgelen
Thorax Centrum Twente
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Target vessel failure (TVF): a composite of Cardiac death, Target vessel related Myocardial Infarction and Clinically driven repeated target vessel revascularization
Time Frame: 1 year