Coronary Artery Disease Clinical Trial
— BIONYXOfficial title:
Bioresorbable Polymer ORSIRO Versus Durable Polymer RESOLUTE ONYX Stents (BIONYX): A Randomized Trial With Stent Evaluation in All-comers IV (TWENTE IV)
Verified date | February 2017 |
Source | Thorax Centrum Twente |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The 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 bioresorbable 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 bioresorbable polymer DES are increasingly used in clinical practice, data from head-to-head comparisons between bioresorbable polymer DES with a contemporary highly flexible new generation permanent polymer coated DES.
Status | Active, not recruiting |
Enrollment | 2470 |
Est. completion date | March 2019 |
Est. primary completion date | March 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - Known intolerance to components of one of the study DES, or known intolerance to antithrombotic and/or anticoagulant therapy that prevents adherence to any dual anti-platelet therapy (DAPT). - Planned elective surgical procedure necessitating interruption of DAPT during the first 3 months after randomization. - Participation in another randomized cardiovascular device trial or randomized pharmacological study related to antithrombotic and/or anticoagulant therapy before reaching the primary endpoint. - Known pregnancy, adherence to scheduled follow-up is unlikely, or life expectancy is assumed to be less than 1 year |
Country | Name | City | State |
---|---|---|---|
Belgium | CHU Charleroi | Charleroi | |
Belgium | Jessa Ziekenhuis | Hasselt | |
Israel | Rambam | Haifa | |
Netherlands | Rijnstate Hospital | Arnhem | |
Netherlands | Haga Ziekenhuis | Den Haag | Zuid Holland |
Netherlands | Treant Zorggroep | Emmen | |
Netherlands | Medisch Spectrum Twente | Enschede |
Lead Sponsor | Collaborator |
---|---|
Thorax Centrum Twente |
Belgium, Israel, Netherlands,
Sen H, Lam MK, Löwik MM, Danse PW, Jessurun GA, van Houwelingen KG, Anthonio RL, Tjon Joe Gin RM, Hautvast RW, Louwerenburg JH, de Man FH, Stoel MG, van der Heijden LC, Linssen GC, IJzerman MJ, Tandjung K, Doggen CJ, von Birgelen C. Clinical Events and Patient-Reported Chest Pain in All-Comers Treated With Resolute Integrity and Promus Element Stents: 2-Year Follow-Up of the DUTCH PEERS (DUrable Polymer-Based STent CHallenge of Promus ElemEnt Versus ReSolute Integrity) Randomized Trial (TWENTE II). JACC Cardiovasc Interv. 2015 Jun;8(7):889-99. doi: 10.1016/j.jcin.2015.01.033. — View Citation
von Birgelen C, Sen H, Lam MK, Danse PW, Jessurun GA, Hautvast RW, van Houwelingen GK, Schramm AR, Gin RM, Louwerenburg JW, de Man FH, Stoel MG, Löwik MM, Linssen GC, Saïd SA, Nienhuis MB, Verhorst PM, Basalus MW, Doggen CJ, Tandjung K. Third-generation zotarolimus-eluting and everolimus-eluting stents in all-comer patients requiring a percutaneous coronary intervention (DUTCH PEERS): a randomised, single-blind, multicentre, non-inferiority trial. Lancet. 2014 Feb 1;383(9915):413-23. doi: 10.1016/S0140-6736(13)62037-1. Erratum in: Lancet. 2014 Feb 1;383(9915):412. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Longitudinal stent deformation (LSD) and deliverability | Identification of deformation of a stent in the longitudinal axis during coronary angiographic assessment. | 1 year | |
Primary | Target vessel failure (TVF) | Composite endpoint consisting of: Cardiac death (All deaths are considered cardiac, unless an unequivocal non-cardiac cause can be established); Target vessel related MI (Q-wave or non-Q-wave myocardial infarction that can be related to the target vessel or cannot be related to another vessel); Clinically driven repeated target vessel revascularization by means of CABG or PCI. | 1 year | |
Secondary | Death at 1 and 2 year follow-up | Death distinguished into: cardiac, vascular, other causes, all-cause mortality | 1 and 2 year | |
Secondary | Myocardial infarction at 1 and 2 year follow-up | Myocardial infarction distinguished into Q-wave and non-Q-wave myocardial infarction | 1 and 2 year | |
Secondary | Revascularization at 1 and 2 year follow-up | Target-vessel revascularization distinguished into PCI or CABG | 1 and 2 year | |
Secondary | Stent thrombosis at 1 and 2 year follow-up | Stent thrombosis was distinguished into definite, probable and possible according to the Academic Research Consortium (ARC) definition. | 1 and 2 year | |
Secondary | Target lesion failure (TLF) at 1 and 2 year follow-up | Composite endpoint consisting of : cardiac death; target vessel-related MI; clinically driven target lesion revascularization (TLR) | 1 and 2 year | |
Secondary | Major adverse cardiac events (MACE) at 1 and 2 year follow-up | Composite endpoint consisting of: any death; any myocardial infarction emergent CABG; clinically indicated TLR |
1 and 2 year follow-up | |
Secondary | Patient oriented composite endpoint (POCE) at 1 and 2 year follow-up | Composite endpoint consisting of: any death; any myocardial infarction; any revascularization. | 1 and 2 year follow-up | |
Secondary | Major Bleeding at 1 and 2 year follow-up | Major bleeding that require surgery or blood transfusions or cerebral hemorrhages | 1 and 2 year follow-up |
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