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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).


- candidate number13266
- NTR NumberNTR3592
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR29-aug-2012
- Secondary IDsP12-22 METC MST
- Public TitleComparison 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).
- Scientific TitleComparison 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).
- ACRONYMBIO-RESORT
- hypothesisThe aim of the study is to compare the outcome of two DES with biodegradable polymer coatings separately (Orsiro and Synergy) versus an established third-generation durable polymer DES with proven efficacy and safety (Resolute Integrity) in an all comers patient population and non-inferiority setting.
- Healt Condition(s) or Problem(s) studiedPercutaneous Coronary Intervention (PCI), Coronary atherosclerosis
- Inclusion criteria1. 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;
3. Capable of providing informed consent;
4. Patients with all clinical syndromes will be enrolled without any exclusion based on number, type, location, or length of lesions to be treated.
- Exclusion criteria1. 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;
3. Participation in another randomized drug or device trial before reaching primary endpoint;
4. Adherence to scheduled follow-up is unlikely or life expectancy assumed to be less than 1 year;
5. Known pregnancy.
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-nov-2012
- planned closingdate1-nov-2016
- Target number of participants3540
- InterventionsIntervention will involve randomization of the type of DES (Orsiro or Synergy or Resolute integrity) used in study population.
- Primary outcome1. Target vessel failure (TVF) at 12 months (according to ARC definitions) after randomization of Orsiro and Synergy will be compared to Resolute Integrity.
Components of the primary endpoint in hierarchical order:
1. Cardiac death. All deaths are considered cardiac, unless an unequivocal non-cardiac cause can be established;
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;
3. Clinically driven repeated target vessel revascularization by means of CABG or PCI.
- Secondary outcomeDevice 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.
- TimepointsBaseline, 1 month, 1 year, 2 years.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. H. Verheij
- CONTACT for SCIENTIFIC QUERIESProf. Dr. C. Birgelen, von
- Sponsor/Initiator
- Funding
(Source(s) of Monetary or Material Support)
Cardio Research Enschede BV
- PublicationsN/A
- Brief summaryThe introduction of drug-eluting stents (DES) in the treatment of coronary artery disease has led to a significant reduction in morbidity. However, the first generation of these devices had no positive impact on the mortality after PCI (compared to bare metal stents), which was greatly attributed to a somewhat increased incidence of late and very late stent thrombosis. Concerns about the role of durable polymers as a potential trigger of inflammation and finally adverse events also led to the development of DES with biodegradable coatings, which leave after degradation of the coating only a bare metal stent in the vessel wall that does not induce an inflammatory response. While such biodegradable polymer DES are increasingly used in clinical practice, there is no data available from head-to-head comparisons between biodegradable and contemporary third generation durable polymer DES.
- Main changes (audit trail)
- RECORD29-aug-2012 - 12-sep-2012


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