Coronary Artery DiseaseBIONYXNCT02508714
Bioresorbable Polymer ORSIRO Versus Durable Polymer RESOLUTE ONYX Stents
A study testing Orsiro and Resolute Onyx in people with Coronary Artery Disease and Angina Pectoris, run by Thorax Centrum Twente at 7 sites in 3 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Angina Pectoris, Unstable Angina Pectoris
- What is being tested?
- Orsiro and Resolute Onyx
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,470 participants
- Where
- 7 sitesin 3 countries
- Study dates
- 7 Oct 2016to Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
Netherlands4 sites
Rijnstate Hospital
Arnhem
Treant Zorggroep
Emmen
Medisch Spectrum Twente
Enschede
Haga Ziekenhuis
The Hague, South Holland, 2504 LN
About this study
Official title: Bioresorbable Polymer ORSIRO Versus Durable Polymer RESOLUTE ONYX Stents (BIONYX): A Randomized Trial With Stent Evaluation in All-comers IV (TWENTE IV)
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.
Read the detailed description
rationale: 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.
Aim:
The aim of the study is to compare the outcome of the bioresorbable polymer coated stent (ORSIRO) and a new generation permanent polymer coated stent (RESOLUTE ONYX) in an all-comers patient population and non-inferiority setting.
Study design:
The study is a prospective, randomized, single-blinded, multicentre trial with 1:1 randomization for drug-eluting stent type, stratified for gender and the presence of diabetes mellitus.
Study population:
Patients who require percutaneous coronary intervention (PCI) for the treatment of coronary stenoses with an indication for DES use, according to current guidelines and/or the operators clinical judgement. All clinical syndromes will be included. A total of 2,470 patients will be included.
Intervention:
One group will receive the ORSIRO stent, the other group will receive the RESOLUTE ONYX stent. All other intervention and procedural characteristics are similar.
Primary study outcome:
Incidence of target vessel failure (TVF) at 1 year follow-up (according to ARC definitions). Components of the primary endpoint in hierarchical order: - Cardiac death: all deaths are considered cardiac, unless an unequivocal non-cardiac cause can be established. - Target vessel related myocardial infarction (MI) that is Q-wave or non-Q-wave, that can be related to the target vessel or cannot be related to another vessel. - Clinically driven repeated target vessel revascularization by means of PCI or coronary artery bypass grafting (CABG).
- Conditions
- Coronary Artery Disease, Angina Pectoris, Unstable Angina Pectoris, Acute Coronary Syndrome, Coronary Stenosis, Coronary Restenosis
- Being tested
- Orsiro, Resolute Onyx
- Medical subject headings
- Coronary Artery Disease, Angina Pectoris, Angina, Unstable, Acute Coronary Syndrome, Coronary Stenosis, Coronary Restenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OrsiroDevice
Also called Orsiro drug eluting stent
stents will be implanted in case of significant coronary artery disease
Resolute OnyxDevice
Also called Resolute Onyx drug eluting stent
stents will be implanted in case of significant coronary artery disease based on coronary angiography
| Study group | Role | What they receive |
|---|---|---|
| Orsiro DES (Biotronik) | Active comparator | The ORSIRO hybrid coating DES (Biotronik, Switzerland) is a device which includes a modern, highly flexible, thin-strut stent platform, eluting sirolimus from a thin biodegradable BIO-lute coating grom PLLA (poly(L-lactic acid)) which is located mainly on the abluminal side. Receives: Device: Orsiro |
| RESOLUTE ONYX DES (Medtronic) | Active comparator | The RESOLUTE ONYX is a permanent polymer DES that uses a novel highly flexible metallic stent backbone with increased radiographic visibility eluting the drug zotarolimus from the BioLinx durable polymer coating. The stent platform uses corewire technology that allows the stent to have a denser core metal surrounded by outer layer of cobalt-chromium. Receives: Device: Resolute Onyx |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (8)
Death at 1 and 2 year follow-up
Death distinguished into: cardiac, vascular, other causes, all-cause mortality
Measured: 1 and 2 year
Myocardial infarction at 1 and 2 year follow-up
Myocardial infarction distinguished into Q-wave and non-Q-wave myocardial infarction
Measured: 1 and 2 year
Revascularization at 1 and 2 year follow-up
Target-vessel revascularization distinguished into PCI or CABG
Measured: 1 and 2 year
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.
Measured: 1 and 2 year
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)
Measured: 1 and 2 year
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
Measured: 1 and 2 year follow-up
Patient oriented composite endpoint (POCE) at 1 and 2 year follow-up
Composite endpoint consisting of: any death; any myocardial infarction; any revascularization.
Measured: 1 and 2 year follow-up
Major Bleeding at 1 and 2 year follow-up
Major bleeding that require surgery or blood transfusions or cerebral hemorrhages
Measured: 1 and 2 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2015 (estimated)
- Study start7 Oct 2016
- Primary completionMar 2018 (estimated)
- Study completionMar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 2,470 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thorax Centrum Twente
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Clemens von Birgelen, Thorax Centrum Twente
- Investigators
- Clemens von Birgelen, MD, PhD, Principal investigator, Thorax Centrum Twente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02508714
- Sponsor's protocol ID
- P15-19
- Acronym
- BIONYX
- Status last verified
- Feb 2017
- First submitted
- 23 Jul 2015
- Last updated
- 3 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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, Lowik MM, Linssen GC, Said 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. Epub 2013 Oct 31.
PubMed 24183564Sen H, Lam MK, Lowik 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. Epub 2015 May 20.
PubMed 26003019van Vliet D, Pinxterhuis TH, Ploumen EH, Kok MM, Buiten RA, Zocca P, Roguin A, Schotborgh CE, Anthonio RL, Danse PW, Benit E, Aminian A, Doggen CJM, von Birgelen C. Impact of diabetes on three-year outcome after coronary stenting in patients with polyvascular atherosclerotic disease - a secondary analysis of the randomized TWENTE trials. Int J Cardiol Heart Vasc. 2025 Jul 6;59:101741. doi: 10.1016/j.ijcha.2025.101741. eCollection 2025 Aug.
PubMed 40687396van Vliet D, Ploumen EH, Pinxterhuis TH, Doggen CJM, Aminian A, Schotborgh CE, Danse PW, Roguin A, Anthonio RL, Benit E, Kok MM, Linssen GCM, von Birgelen C. Elderly patients treated with Onyx versus Orsiro drug-eluting coronary stents in a randomized clinical trial with long-term follow-up. Clin Res Cardiol. 2025 Dec;114(12):1681-1691. doi: 10.1007/s00392-025-02622-7. Epub 2025 Mar 4.
PubMed 40035811van Vliet D, Ploumen EH, Pinxterhuis TH, Buiten RA, Aminian A, Schotborgh CE, Danse PW, Roguin A, Anthonio RL, Benit E, Zocca P, Doggen CJM, von Birgelen C. Final 5-year report of BIONYX comparing the thin-composite wire-strut zotarolimus-eluting stent versus ultrathin-strut sirolimus-eluting stent. Catheter Cardiovasc Interv. 2024 Jul;104(1):1-9. doi: 10.1002/ccd.31067. Epub 2024 May 7.
PubMed 38713843Pinxterhuis TH, Ploumen EH, Zocca P, Doggen CJM, Schotborgh CE, Anthonio RL, Roguin A, Danse PW, Benit E, Aminian A, Hartmann M, Linssen GCM, von Birgelen C. Impact of premature coronary artery disease on adverse event risk following first percutaneous coronary intervention. Front Cardiovasc Med. 2023 Sep 7;10:1160201. doi: 10.3389/fcvm.2023.1160201. eCollection 2023.
PubMed 37745109Pinxterhuis TH, Ploumen EH, Zocca P, Doggen CJM, Schotborgh CE, Anthonio RL, Roguin A, Danse PW, Benit E, Aminian A, van Houwelingen KG, Linssen GCM, Geelkerken RH, von Birgelen C. Outcome of percutaneous coronary intervention using ultrathin-strut biodegradable polymer sirolimus-eluting versus thin-strut durable polymer zotarolimus-eluting stents in patients with comorbid peripheral arterial disease: a post-hoc analysis from two randomized trials. Cardiovasc Diagn Ther. 2023 Aug 31;13(4):673-685. doi: 10.21037/cdt-22-584. Epub 2023 Jul 24.
PubMed 37675090Pinxterhuis TH, Ploumen EH, Doggen CJM, Hartmann M, Schotborgh CE, Anthonio RL, Roguin A, Danse PW, Benit E, Aminian A, Linssen GCM, von Birgelen C. First myocardial infarction in patients with premature coronary artery disease: insights into patient characteristics and outcome after treatment with contemporary stents. Eur Heart J Acute Cardiovasc Care. 2023 Nov 16;12(11):774-781. doi: 10.1093/ehjacc/zuad098.
PubMed 37619976Pinxterhuis TH, Ploumen EH, Zocca P, Doggen CJM, Schotborgh CE, Anthonio RL, Roguin A, Danse PW, Benit E, Aminian A, Stoel MG, Linssen GCM, Geelkerken RH, von Birgelen C. Outcome after percutaneous coronary intervention with contemporary stents in patients with concomitant peripheral arterial disease: A patient-level pooled analysis of four randomized trials. Atherosclerosis. 2022 Aug;355:52-59. doi: 10.1016/j.atherosclerosis.2022.05.002. Epub 2022 May 20.
PubMed 35641327Ploumen EH, Pinxterhuis TH, Zocca P, Roguin A, Anthonio RL, Schotborgh CE, Benit E, Aminian A, Danse PW, Doggen CJM, von Birgelen C, Kok MM. Impact of prediabetes and diabetes on 3-year outcome of patients treated with new-generation drug-eluting stents in two large-scale randomized clinical trials. Cardiovasc Diabetol. 2021 Oct 30;20(1):217. doi: 10.1186/s12933-021-01405-4.
PubMed 34717627Ploumen EH, Buiten RA, Zocca P, Doggen CJ, Aminian A, Schotborgh CE, Jessurun GA, Roguin A, Danse PW, Benit E, von Birgelen C. First Report of 3-Year Clinical Outcome After Treatment With Novel Resolute Onyx Stents in the Randomized BIONYX Trial. Circ J. 2021 Oct 25;85(11):1983-1990. doi: 10.1253/circj.CJ-21-0292. Epub 2021 Jul 13.
PubMed 34261828von Birgelen C, Zocca P, Buiten RA, Jessurun GAJ, Schotborgh CE, Roguin A, Danse PW, Benit E, Aminian A, van Houwelingen KG, Anthonio RL, Stoel MG, Somi S, Hartmann M, Linssen GCM, Doggen CJM, Kok MM. Thin composite wire strut, durable polymer-coated (Resolute Onyx) versus ultrathin cobalt-chromium strut, bioresorbable polymer-coated (Orsiro) drug-eluting stents in allcomers with coronary artery disease (BIONYX): an international, single-blind, randomised non-inferiority trial. Lancet. 2018 Oct 6;392(10154):1235-1245. doi: 10.1016/S0140-6736(18)32001-4. Epub 2018 Sep 22.
PubMed 30253879van der Heijden LC, Kok MM, Zocca P, Jessurun GAJ, Schotborgh CE, Roguin A, Benit E, Aminian A, Danse PW, Lowik MM, Linssen GCM, van der Palen J, Doggen CJM, von Birgelen C. Bioresorbable Polymer-Coated Orsiro Versus Durable Polymer-Coated Resolute Onyx Stents (BIONYX): Rationale and design of the randomized TWENTE IV multicenter trial. Am Heart J. 2018 Apr;198:25-32. doi: 10.1016/j.ahj.2017.12.011. Epub 2017 Dec 21.
PubMed 29653644
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioresorbable Polymer ORSIRO Versus Durable Polymer RESOLUTE ONYX Stents (BIONYX): A Randomized Trial With Stent Evaluation in All-comers IV (TWENTE IV)
- ClinicalTrials.gov ID
- NCT02508714
- Acronym / sponsor ID
- BIONYX / P15-19
- Conditions
- Coronary Artery Disease, Angina Pectoris, Unstable Angina Pectoris, Acute Coronary Syndrome, Coronary Stenosis, Coronary Restenosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,470 participants (actual)
- Lead sponsor
- Thorax Centrum TwenteUniversity, hospital or other
- Study start
- 7 Oct 2016 (actual)
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 27 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
rationale: 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.
Aim:
The aim of the study is to compare the outcome of the bioresorbable polymer coated stent (ORSIRO) and a new generation permanent polymer coated stent (RESOLUTE ONYX) in an all-comers patient population and non-inferiority setting.
Study design:
The study is a prospective, randomized, single-blinded, multicentre trial with 1:1 randomization for drug-eluting stent type, stratified for gender and the presence of diabetes mellitus.
Study population:
Patients who require percutaneous coronary intervention (PCI) for the treatment of coronary stenoses with an indication for DES use, according to current guidelines and/or the operators clinical judgement. All clinical syndromes will be included. A total of 2,470 patients will be included.
Intervention:
One group will receive the ORSIRO stent, the other group will receive the RESOLUTE ONYX stent. All other intervention and procedural characteristics are similar.
Primary study outcome:
Incidence of target vessel failure (TVF) at 1 year follow-up (according to ARC definitions). Components of the primary endpoint in hierarchical order: - Cardiac death: all deaths are considered cardiac, unless an unequivocal non-cardiac cause can be established. - Target vessel related myocardial infarction (MI) that is Q-wave or non-Q-wave, that can be related to the target vessel or cannot be related to another vessel. - Clinically driven repeated target vessel revascularization by means of PCI or coronary artery bypass grafting (CABG).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Orsiro DES (Biotronik) | Active comparator | Device: OrsiroThe ORSIRO hybrid coating DES (Biotronik, Switzerland) is a device which includes a modern, highly flexible, thin-strut stent platform, eluting sirolimus from a thin biodegradable BIO-lute coating grom PLLA (poly(L-lactic acid)) which is located mainly on the abluminal side. |
| RESOLUTE ONYX DES (Medtronic) | Active comparator | Device: Resolute OnyxThe RESOLUTE ONYX is a permanent polymer DES that uses a novel highly flexible metallic stent backbone with increased radiographic visibility eluting the drug zotarolimus from the BioLinx durable polymer coating. The stent platform uses corewire technology that allows the stent to have a denser core metal surrounded by outer layer of cobalt-chromium. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OrsiroAlso: Orsiro drug eluting stentstents will be implanted in case of significant coronary artery disease | Device | Orsiro DES (Biotronik) |
| Resolute OnyxAlso: Resolute Onyx drug eluting stentstents will be implanted in case of significant coronary artery disease based on coronary angiography | Device | RESOLUTE ONYX DES (Medtronic) |
Primary outcome
Target vessel failure (TVF)
Time frame: 1 year
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.
8 secondary outcomes
Death at 1 and 2 year follow-up
Time frame: 1 and 2 year
Myocardial infarction at 1 and 2 year follow-up
Time frame: 1 and 2 year
Revascularization at 1 and 2 year follow-up
Time frame: 1 and 2 year
Stent thrombosis at 1 and 2 year follow-up
Time frame: 1 and 2 year
Target lesion failure (TLF) at 1 and 2 year follow-up
Time frame: 1 and 2 year
Major adverse cardiac events (MACE) at 1 and 2 year follow-up
Time frame: 1 and 2 year follow-up
Patient oriented composite endpoint (POCE) at 1 and 2 year follow-up
Time frame: 1 and 2 year follow-up
Major Bleeding at 1 and 2 year follow-up
Time frame: 1 and 2 year follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2017.
- Background: PubMed 24183564von 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, Lowik MM, Linssen GC, Said 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. Epub 2013 Oct 31.
- Background: PubMed 26003019Sen H, Lam MK, Lowik 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. Epub 2015 May 20.
- Derived from this study: PubMed 40687396van Vliet D, Pinxterhuis TH, Ploumen EH, Kok MM, Buiten RA, Zocca P, Roguin A, Schotborgh CE, Anthonio RL, Danse PW, Benit E, Aminian A, Doggen CJM, von Birgelen C. Impact of diabetes on three-year outcome after coronary stenting in patients with polyvascular atherosclerotic disease - a secondary analysis of the randomized TWENTE trials. Int J Cardiol Heart Vasc. 2025 Jul 6;59:101741. doi: 10.1016/j.ijcha.2025.101741. eCollection 2025 Aug.
- Derived from this study: PubMed 40035811van Vliet D, Ploumen EH, Pinxterhuis TH, Doggen CJM, Aminian A, Schotborgh CE, Danse PW, Roguin A, Anthonio RL, Benit E, Kok MM, Linssen GCM, von Birgelen C. Elderly patients treated with Onyx versus Orsiro drug-eluting coronary stents in a randomized clinical trial with long-term follow-up. Clin Res Cardiol. 2025 Dec;114(12):1681-1691. doi: 10.1007/s00392-025-02622-7. Epub 2025 Mar 4.
- Derived from this study: PubMed 38713843van Vliet D, Ploumen EH, Pinxterhuis TH, Buiten RA, Aminian A, Schotborgh CE, Danse PW, Roguin A, Anthonio RL, Benit E, Zocca P, Doggen CJM, von Birgelen C. Final 5-year report of BIONYX comparing the thin-composite wire-strut zotarolimus-eluting stent versus ultrathin-strut sirolimus-eluting stent. Catheter Cardiovasc Interv. 2024 Jul;104(1):1-9. doi: 10.1002/ccd.31067. Epub 2024 May 7.
- Derived from this study: PubMed 37745109Pinxterhuis TH, Ploumen EH, Zocca P, Doggen CJM, Schotborgh CE, Anthonio RL, Roguin A, Danse PW, Benit E, Aminian A, Hartmann M, Linssen GCM, von Birgelen C. Impact of premature coronary artery disease on adverse event risk following first percutaneous coronary intervention. Front Cardiovasc Med. 2023 Sep 7;10:1160201. doi: 10.3389/fcvm.2023.1160201. eCollection 2023.
- Derived from this study: PubMed 37675090Pinxterhuis TH, Ploumen EH, Zocca P, Doggen CJM, Schotborgh CE, Anthonio RL, Roguin A, Danse PW, Benit E, Aminian A, van Houwelingen KG, Linssen GCM, Geelkerken RH, von Birgelen C. Outcome of percutaneous coronary intervention using ultrathin-strut biodegradable polymer sirolimus-eluting versus thin-strut durable polymer zotarolimus-eluting stents in patients with comorbid peripheral arterial disease: a post-hoc analysis from two randomized trials. Cardiovasc Diagn Ther. 2023 Aug 31;13(4):673-685. doi: 10.21037/cdt-22-584. Epub 2023 Jul 24.
- Derived from this study: PubMed 37619976Pinxterhuis TH, Ploumen EH, Doggen CJM, Hartmann M, Schotborgh CE, Anthonio RL, Roguin A, Danse PW, Benit E, Aminian A, Linssen GCM, von Birgelen C. First myocardial infarction in patients with premature coronary artery disease: insights into patient characteristics and outcome after treatment with contemporary stents. Eur Heart J Acute Cardiovasc Care. 2023 Nov 16;12(11):774-781. doi: 10.1093/ehjacc/zuad098.
- Derived from this study: PubMed 35641327Pinxterhuis TH, Ploumen EH, Zocca P, Doggen CJM, Schotborgh CE, Anthonio RL, Roguin A, Danse PW, Benit E, Aminian A, Stoel MG, Linssen GCM, Geelkerken RH, von Birgelen C. Outcome after percutaneous coronary intervention with contemporary stents in patients with concomitant peripheral arterial disease: A patient-level pooled analysis of four randomized trials. Atherosclerosis. 2022 Aug;355:52-59. doi: 10.1016/j.atherosclerosis.2022.05.002. Epub 2022 May 20.
- Derived from this study: PubMed 34717627Ploumen EH, Pinxterhuis TH, Zocca P, Roguin A, Anthonio RL, Schotborgh CE, Benit E, Aminian A, Danse PW, Doggen CJM, von Birgelen C, Kok MM. Impact of prediabetes and diabetes on 3-year outcome of patients treated with new-generation drug-eluting stents in two large-scale randomized clinical trials. Cardiovasc Diabetol. 2021 Oct 30;20(1):217. doi: 10.1186/s12933-021-01405-4.
- Derived from this study: PubMed 34261828Ploumen EH, Buiten RA, Zocca P, Doggen CJ, Aminian A, Schotborgh CE, Jessurun GA, Roguin A, Danse PW, Benit E, von Birgelen C. First Report of 3-Year Clinical Outcome After Treatment With Novel Resolute Onyx Stents in the Randomized BIONYX Trial. Circ J. 2021 Oct 25;85(11):1983-1990. doi: 10.1253/circj.CJ-21-0292. Epub 2021 Jul 13.
- Derived from this study: PubMed 30253879von Birgelen C, Zocca P, Buiten RA, Jessurun GAJ, Schotborgh CE, Roguin A, Danse PW, Benit E, Aminian A, van Houwelingen KG, Anthonio RL, Stoel MG, Somi S, Hartmann M, Linssen GCM, Doggen CJM, Kok MM. Thin composite wire strut, durable polymer-coated (Resolute Onyx) versus ultrathin cobalt-chromium strut, bioresorbable polymer-coated (Orsiro) drug-eluting stents in allcomers with coronary artery disease (BIONYX): an international, single-blind, randomised non-inferiority trial. Lancet. 2018 Oct 6;392(10154):1235-1245. doi: 10.1016/S0140-6736(18)32001-4. Epub 2018 Sep 22.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clemens von Birgelen, MD, PhD principal investigator
Thorax Centrum Twente
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Orsiro and Resolute Onyx in people with Coronary Artery Disease and Angina Pectoris, run by Thorax Centrum Twente at 7 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Netherlands, Belgium, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target vessel failure (TVF) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02508714, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2017.