Comparison of BIOdegradable Polymer and DuRablE Polymer Drug-eluting Stents in an All COmeRs PopulaTion: Randomized Multicenter Trial in an All Comers Population Treated Within thE NeThErlands 3 (TWENTE 3).
- Conditions
- Percutaneous Coronary Intervention (PCI), Coronary atherosclerosis
- Registration Number
- NL-OMON28886
- Lead Sponsor
- Cardio Research Enschede BV
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 3540
Inclusion Criteria
1. Minimum age of 18 years;
2. Significant coronary artery disease and lesion(s) eligible for treatment with drug eluting stents according to clinical guidelines and/or the operators' judgement;
Exclusion Criteria
1. Known intolerance to components of one of the stents that will be investigated or known intolerance to antithrombotic and/or anticoagulant therapy that prevents adherence to dual antiplatelet therapy;
2. Planned elective surgical procedure necessitating interruption of dual antiplatelet therapy during the first 6 months after randomization;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Target vessel failure (TVF) at 12 months (according to ARC definitions) after randomization of Orsiro and Synergy will be compared to Resolute Integrity.<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 Device and patient oriented effectivity and safety parameters such as target-lesion failure, major adverse cardiac events and patient oriented composite endpoint and stent thrombosis, as well as clinical short- and long-term outcome, and the acute angiographic results of the implantation of Orsiro and Synergy will be compared to Resolute Integrity.