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).
Recruiting
- Conditions
- Percutaneous Coronary Intervention (PCI)Drug-eluting stentCoronary atherosclerosis
- Registration Number
- NL-OMON21654
- Lead Sponsor
- Medisch Spectrum Twente
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 1788
Inclusion Criteria
1. Minimum age of 18 years;
2. Coronary artery disease and lesion(s) eligable for treatment with drug eluting stents according to clinical guidelines and/or the operators’ judgement;
Exclusion Criteria
1. Participation in another randomized drug or device study before reaching primary endpoint;
2. Planned surgery within 6 months of PCI unless dual antiplatelet therapy is maintained throughout the peri-surgical period;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main study parameter/endpoint:<br /> <br>Target vessel failure (TVF) at 12 months (according to ARC definitions).<br><br /><br /><br>Components of the primary endpoint in hierarchical order:<br /><br>1. Cardiac death. All deaths are considered cardiac, unless an unequivocal non-cardiac cause can be established;<br /><br>2. Target vessel related MI that is Q-wave or non-Q-wave myocardial infarction that can be related to the target vessel or cannot be related to another vessel;<br /><br>3. Clinically driven repeated target vessel revascularization by means of CABG or PCI.
- Secondary Outcome Measures
Name Time Method