Comparison of BIOdegradable Polymer and DuRablE Polymer Drug-eluting Stents in an All COmeRs PopulaTion (BIO-RESORT): Randomized Multicenter Trial in an All Comers Population Treated Within thE NeThErlands 3 (TWENTE 3)
- Conditions
- arteriosclerosehardening of the arteries100110821000759310003216
- Registration Number
- NL-OMON43651
- Lead Sponsor
- Medisch Spectrum Twente
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 3540
Patients of 18 years and older, requiring PCI for the treatment of significant coronary artery or bypass graft lesions, being eligible for treatment with drug eluting stents according to clinical guidelines and/or the operators* judgement, and capable of providing informed consent. Patients with all clinical syndromes will be enrolled without any exclusion based on number, type, location, or length of lesions to be treated.
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.
Planned elective surgical procedure necessitating interruption of dual antiplatelet therapy during the first 6 months after randomization. Participation in another randomized drug or device trial before reaching primary endpoint. Adherence to scheduled follow-up is unlikely or life expectancy assumed to be less than 1 year.
Known pregnancy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Incidence of target vessel failure (TVF) at 1 year follow-up (according to ARC<br /><br>definitions). Components of the primary endpoint in hierarchical order: o<br /><br>Cardiac death. All deaths are considered cardiac, unless an unequivocal<br /><br>non-cardiac cause can be established. o Target vessel related MI that is Q-wave<br /><br>or non-Q-wave myocardial infarction that can be related to the target vessel or<br /><br>cannot be related to another vessel. o Clinically driven repeated target vessel<br /><br>revascularization by means of CABG or PCI</p><br>
- Secondary Outcome Measures
Name Time Method