Coronary Artery DiseasePhase 4TWENTENCT01066650
The Real-World Endeavor Resolute Versus XIENCE V Drug-Eluting Stent Study in Twente
A Phase 4 study testing Endeavor Resolute (Biolinx-based Zotarolimus-eluting stent) and Xience V (Everolimus-eluting stent) in people with Coronary Artery Disease and Angina Pectoris, run by Foundation of Cardiovascular Research and Education Enschede at 1 site in Netherlands.
Trial summary
The TWENTE Study is a single center prospective single-blinded randomized study. Randomization will involve the type of Drug-Eluting Stent (DES) used in study population. Patients will be blinded to the type of DES they will receive. 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?
- Endeavor Resolute (Biolinx-based Zotarolimus-eluting stent) and Xience V (Everolimus-eluting stent)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,391 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2008to Sep 2012
- Phase
- Phase 4
- 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
- Indication for PCI with DES implantation based on VVC/ESC guidelines and/or clinical decision of interventional cardiologist
- Age ≥ 18 years and mentally capable to give an informed consent
- Signed informed consent
Who cannot join
- Patients with ST-elevation myocardial infarction (STEMI) or an ST- elevation myocardial infarction equivalent requiring primary PCI or rescue PCI
- Patients in whom the revascularization procedure is planned to be performed in a staged approach
- Renal failure requiring haemodialysis
- Patient is currently participating in an investigational drug or device study that has been not completed
- In the investigators opinion patient has a co-morbid condition(s) that could limit the patient's ability to participate in the study, compliance with follow-up requirements or impact the scientific integrity of the study
- Life expectancy less than 1 year
- Patients in whom during PCI there is no indication for DES use and/or if the operator chooses not to use a DES based on the clinical situation, the patient will be excluded.
- If the choice of DES is dictated by logistic reasons e.g. the required DES dimensions is provided by one manufacturer only.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Real-World Endeavor Resolute Versus XIENCE V Drug-Eluting SteNt Study: Head-to-head Comparison of Clinical Outcome After Implantation of Second Generation Drug-eluting Stents in a Real World Scenario
The TWENTE Study is a single center prospective single-blinded randomized study. Randomization will involve the type of Drug-Eluting Stent (DES) used in study population. Patients will be blinded to the type of DES they will receive. The general practitioner of the patient will be requested not to disclose this information to the patient. Analysts who perform the data analyses will be blinded to the type DES used as well.
Read the detailed description
Primary research questions
To investigate whether the clinical outcome following the randomized implantation of the Endeavor Resolute® versus XIENCE V® drug-eluting stent is similar, as assessed in a non-inferiority setting by comparing target-vessel failure (TVF) of both stents. We want to compare for both drug-eluting stents the combined endpoint of death, myocardial infarction or revascularization related to the target-vessel, as well as death or myocardial infarction that cannot be related to a significant flow obstruction in another vessel or to another cause. According to current literature, non-inferiority of Endeavor resolute ® and XIENCE V® is expected. But the non-inferiority of Endeavor resolute and XIENCE V® is not tested in a controlled randomized trial yet.
- Conditions
- Coronary Artery Disease, Angina Pectoris, Unstable Angina Pectoris, Coronary Stenosis, Coronary Restenosis
- Being tested
- Endeavor Resolute (Biolinx-based Zotarolimus-eluting stent), Xience V (Everolimus-eluting stent)
- Keywords
- TWENTE, randomized study, stent, coronary stent, drug-eluting stent, Zotarolimus, Everolimus, Xience V, Endeavor Resolute, head to head comparison, real world patients, target vessel failure, investigator initiated study, coronary artery disease, coronary arteries, atherosclerosis, non inferiority
- Medical subject headings
- Coronary Artery Disease, Angina Pectoris, Angina, Unstable, Coronary Stenosis, Coronary Restenosis, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endeavor Resolute (Biolinx-based Zotarolimus-eluting stent)Device
Also called Endeavor Resolute stent
Drug eluting Stent
Xience V (Everolimus-eluting stent)Device
Also called Xience V drug eluting stent
Drug eluting stent
| Study group | Role | What they receive |
|---|---|---|
| Endeavor Resolute | Active comparator | Not described Receives: Device: Endeavor Resolute (Biolinx-based Zotarolimus-eluting stent) |
| Xience V | Active comparator | Not described Receives: Device: Xience V (Everolimus-eluting stent) |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparing target-vessel failure (TVF) of both stents
Measured: 1 year
Secondary outcomes (1)
the efficacy, safety, clinical short- and long-term outcome, and the acute angiographic results of the implantation of two second-generation drug-eluting stents
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2010 (estimated)
- Study startJun 2008
- Primary completionAug 2010
- Study completionSep 2012
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,391 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation of Cardiovascular Research and Education Enschede
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, prof. C. von Birgelen, Thorax Centrum Twente
- Investigators
- C. von Birgelen, MD,PhD,Prof, Principal investigator, Thorax Centrum Twente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01066650
- Sponsor's protocol ID
- TWENTE I
- Other IDs
- MST/Twente/001
- Acronym
- TWENTE
- Status last verified
- Jul 2015
- First submitted
- 9 Feb 2010
- Last updated
- 28 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
van 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 40687396Pinxterhuis TH, Ploumen EH, Doggen CJM, van Vliet D, Kok MM, Zocca P, Hartmann M, van Houwelingen KG, Stoel MG, de Man FHAF, Linssen GCM, von Birgelen C. Sex and age-specific 10-year mortality after coronary stenting: an analysis of two randomized trials. Eur Heart J Open. 2025 Jan 29;5(1):oeaf006. doi: 10.1093/ehjopen/oeaf006. eCollection 2025 Jan.
PubMed 39959922Pinxterhuis TH, Ploumen EH, van Vliet D, Gert van Houwelingen K, Stoel MG, de Man FH, Hartmann M, Zocca P, Linssen GC, Geelkerken RH, Doggen CJ, von Birgelen C. Ten-year mortality after treating obstructive coronary atherosclerosis with contemporary stents in patients with or without concomitant peripheral arterial disease. Atherosclerosis. 2024 May;392:117488. doi: 10.1016/j.atherosclerosis.2024.117488. Epub 2024 Mar 26.
PubMed 38598970Pinxterhuis 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, 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 35641327von Birgelen C, van der Heijden LC, Basalus MW, Kok MM, Sen H, Louwerenburg HW, van Houwelingen KG, Stoel MG, de Man FH, Linssen GC, Tandjung K, Doggen CJ, van der Palen J, Lowik MM. Five-Year Outcome After Implantation of Zotarolimus- and Everolimus-Eluting Stents in Randomized Trial Participants and Nonenrolled Eligible Patients: A Secondary Analysis of a Randomized Clinical Trial. JAMA Cardiol. 2017 Mar 1;2(3):268-276. doi: 10.1001/jamacardio.2016.5190.
PubMed 28114618van Houwelingen KG, Sen H, Lam MK, Tandjung K, Lowik MM, de Man FH, Louwerenburg JH, Stoel MG, Hartmann M, Linssen GC, Doggen CJ, von Birgelen C. Three-year clinical outcome after treatment of chronic total occlusions with second-generation drug-eluting stents in the TWENTE trial. Catheter Cardiovasc Interv. 2015 Feb 15;85(3):E76-82. doi: 10.1002/ccd.25713. Epub 2014 Nov 1.
PubMed 25339110Sen H, Lam MK, Tandjung K, Lowik MM, Stoel MG, de Man FH, Louwerenburg JH, van Houwelingen GK, Linssen GC, Doggen CJ, Basalus MW, von Birgelen C. Complex patients treated with zotarolimus-eluting resolute and everolimus-eluting Xience V stents in the randomized TWENTE trial: comparison of 2-year clinical outcome. Catheter Cardiovasc Interv. 2015 Jan 1;85(1):74-81. doi: 10.1002/ccd.25464. Epub 2014 Mar 14.
PubMed 24585502Tandjung K, Sen H, Lam MK, Basalus MWZ, Louwerenburg JHW, Stoel MG, van Houwelingen KG, de Man FHAF, Linssen GCM, Said SAM, Nienhuis MB, Lowik MM, Verhorst PMJ, van der Palen J, von Birgelen C. Clinical outcome following stringent discontinuation of dual antiplatelet therapy after 12 months in real-world patients treated with second-generation zotarolimus-eluting resolute and everolimus-eluting Xience V stents: 2-year follow-up of the randomized TWENTE trial. J Am Coll Cardiol. 2013 Jun 18;61(24):2406-2416. doi: 10.1016/j.jacc.2013.04.005. Epub 2013 Apr 16.
PubMed 23602769Tandjung K, Basalus MW, Sen H, Stoel MG, van Houwelingen KG, Louwerenburg JH, de Man FH, Linssen GC, Said SA, Kleijne MA, van der Palen J, von Birgelen C. Women treated with second-generation zotarolimus-eluting resolute stents and everolimus-eluting xience V stents: insights from the gender-stratified, randomized, controlled TWENTE trial. Catheter Cardiovasc Interv. 2013 Sep 1;82(3):396-405. doi: 10.1002/ccd.24848. Epub 2013 Mar 8.
PubMed 23359390Sen H, Tandjung K, Basalus MW, Lowik MM, van Houwelingen GK, Stoel MG, Louwerenburg HW, de Man FH, Linssen GC, Nijhuis R, Nienhuis MB, Verhorst PM, van der Palen J, von Birgelen C. Comparison of eligible non-enrolled patients and the randomised TWENTE trial population treated with Resolute and Xience V drug-eluting stents. EuroIntervention. 2012 Oct;8(6):664-71. doi: 10.4244/EIJV8I6A104.
PubMed 22581199von Birgelen C, Basalus MW, Tandjung K, van Houwelingen KG, Stoel MG, Louwerenburg JH, Linssen GC, Said SA, Kleijne MA, Sen H, Lowik MM, van der Palen J, Verhorst PM, de Man FH. A randomized controlled trial in second-generation zotarolimus-eluting Resolute stents versus everolimus-eluting Xience V stents in real-world patients: the TWENTE trial. J Am Coll Cardiol. 2012 Apr 10;59(15):1350-61. doi: 10.1016/j.jacc.2012.01.008. Epub 2012 Feb 15.
PubMed 22341737
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Real-World Endeavor Resolute Versus XIENCE V Drug-Eluting SteNt Study: Head-to-head Comparison of Clinical Outcome After Implantation of Second Generation Drug-eluting Stents in a Real World Scenario
- ClinicalTrials.gov ID
- NCT01066650
- Acronym / sponsor ID
- TWENTE / TWENTE I
- Conditions
- Coronary Artery Disease, Angina Pectoris, Unstable Angina Pectoris, Coronary Stenosis, Coronary Restenosis
- Keywords
- TWENTE, randomized study, stent, coronary stent, drug-eluting stent, Zotarolimus, Everolimus, Xience V
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,391 participants (actual)
- Lead sponsor
- Foundation of Cardiovascular Research and Education EnschedeUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Aug 2010 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 10 Feb 2010 (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 TWENTE Study is a single center prospective single-blinded randomized study. Randomization will involve the type of Drug-Eluting Stent (DES) used in study population. Patients will be blinded to the type of DES they will receive. The general practitioner of the patient will be requested not to disclose this information to the patient. Analysts who perform the data analyses will be blinded to the type DES used as well.
Detailed description
Primary research questions
To investigate whether the clinical outcome following the randomized implantation of the Endeavor Resolute® versus XIENCE V® drug-eluting stent is similar, as assessed in a non-inferiority setting by comparing target-vessel failure (TVF) of both stents. We want to compare for both drug-eluting stents the combined endpoint of death, myocardial infarction or revascularization related to the target-vessel, as well as death or myocardial infarction that cannot be related to a significant flow obstruction in another vessel or to another cause. According to current literature, non-inferiority of Endeavor resolute ® and XIENCE V® is expected. But the non-inferiority of Endeavor resolute and XIENCE V® is not tested in a controlled randomized trial yet.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endeavor Resolute | Active comparator | Device: Endeavor Resolute (Biolinx-based Zotarolimus-eluting stent) |
| Xience V | Active comparator | Device: Xience V (Everolimus-eluting stent) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Indication for PCI with DES implantation based on VVC/ESC guidelines and/or clinical decision of interventional cardiologist
- Age ≥ 18 years and mentally capable to give an informed consent
- Signed informed consent
Key exclusion criteria (8 listed)
- Patients with ST-elevation myocardial infarction (STEMI) or an ST- elevation myocardial infarction equivalent requiring primary PCI or rescue PCI
- Patients in whom the revascularization procedure is planned to be performed in a staged approach
- Renal failure requiring haemodialysis
- Patient is currently participating in an investigational drug or device study that has been not completed
- In the investigators opinion patient has a co-morbid condition(s) that could limit the patient's ability to participate in the study, compliance with follow-up requirements or impact the scientific integrity of the study
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 |
|---|---|---|
| Endeavor Resolute (Biolinx-based Zotarolimus-eluting stent)Also: Endeavor Resolute stentDrug eluting Stent | Device | Endeavor Resolute |
| Xience V (Everolimus-eluting stent)Also: Xience V drug eluting stentDrug eluting stent | Device | Xience V |
Primary outcome
comparing target-vessel failure (TVF) of both stents
Time frame: 1 year
1 secondary outcome
the efficacy, safety, clinical short- and long-term outcome, and the acute angiographic results of the implantation of two second-generation drug-eluting stents
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2015.
- 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 39959922Pinxterhuis TH, Ploumen EH, Doggen CJM, van Vliet D, Kok MM, Zocca P, Hartmann M, van Houwelingen KG, Stoel MG, de Man FHAF, Linssen GCM, von Birgelen C. Sex and age-specific 10-year mortality after coronary stenting: an analysis of two randomized trials. Eur Heart J Open. 2025 Jan 29;5(1):oeaf006. doi: 10.1093/ehjopen/oeaf006. eCollection 2025 Jan.
- Derived from this study: PubMed 38598970Pinxterhuis TH, Ploumen EH, van Vliet D, Gert van Houwelingen K, Stoel MG, de Man FH, Hartmann M, Zocca P, Linssen GC, Geelkerken RH, Doggen CJ, von Birgelen C. Ten-year mortality after treating obstructive coronary atherosclerosis with contemporary stents in patients with or without concomitant peripheral arterial disease. Atherosclerosis. 2024 May;392:117488. doi: 10.1016/j.atherosclerosis.2024.117488. Epub 2024 Mar 26.
- 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 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 28114618von Birgelen C, van der Heijden LC, Basalus MW, Kok MM, Sen H, Louwerenburg HW, van Houwelingen KG, Stoel MG, de Man FH, Linssen GC, Tandjung K, Doggen CJ, van der Palen J, Lowik MM. Five-Year Outcome After Implantation of Zotarolimus- and Everolimus-Eluting Stents in Randomized Trial Participants and Nonenrolled Eligible Patients: A Secondary Analysis of a Randomized Clinical Trial. JAMA Cardiol. 2017 Mar 1;2(3):268-276. doi: 10.1001/jamacardio.2016.5190.
- Derived from this study: PubMed 25339110van Houwelingen KG, Sen H, Lam MK, Tandjung K, Lowik MM, de Man FH, Louwerenburg JH, Stoel MG, Hartmann M, Linssen GC, Doggen CJ, von Birgelen C. Three-year clinical outcome after treatment of chronic total occlusions with second-generation drug-eluting stents in the TWENTE trial. Catheter Cardiovasc Interv. 2015 Feb 15;85(3):E76-82. doi: 10.1002/ccd.25713. Epub 2014 Nov 1.
- Derived from this study: PubMed 24585502Sen H, Lam MK, Tandjung K, Lowik MM, Stoel MG, de Man FH, Louwerenburg JH, van Houwelingen GK, Linssen GC, Doggen CJ, Basalus MW, von Birgelen C. Complex patients treated with zotarolimus-eluting resolute and everolimus-eluting Xience V stents in the randomized TWENTE trial: comparison of 2-year clinical outcome. Catheter Cardiovasc Interv. 2015 Jan 1;85(1):74-81. doi: 10.1002/ccd.25464. Epub 2014 Mar 14.
- Derived from this study: PubMed 23602769Tandjung K, Sen H, Lam MK, Basalus MWZ, Louwerenburg JHW, Stoel MG, van Houwelingen KG, de Man FHAF, Linssen GCM, Said SAM, Nienhuis MB, Lowik MM, Verhorst PMJ, van der Palen J, von Birgelen C. Clinical outcome following stringent discontinuation of dual antiplatelet therapy after 12 months in real-world patients treated with second-generation zotarolimus-eluting resolute and everolimus-eluting Xience V stents: 2-year follow-up of the randomized TWENTE trial. J Am Coll Cardiol. 2013 Jun 18;61(24):2406-2416. doi: 10.1016/j.jacc.2013.04.005. Epub 2013 Apr 16.
- Derived from this study: PubMed 23359390Tandjung K, Basalus MW, Sen H, Stoel MG, van Houwelingen KG, Louwerenburg JH, de Man FH, Linssen GC, Said SA, Kleijne MA, van der Palen J, von Birgelen C. Women treated with second-generation zotarolimus-eluting resolute stents and everolimus-eluting xience V stents: insights from the gender-stratified, randomized, controlled TWENTE trial. Catheter Cardiovasc Interv. 2013 Sep 1;82(3):396-405. doi: 10.1002/ccd.24848. Epub 2013 Mar 8.
- Derived from this study: PubMed 22581199Sen H, Tandjung K, Basalus MW, Lowik MM, van Houwelingen GK, Stoel MG, Louwerenburg HW, de Man FH, Linssen GC, Nijhuis R, Nienhuis MB, Verhorst PM, van der Palen J, von Birgelen C. Comparison of eligible non-enrolled patients and the randomised TWENTE trial population treated with Resolute and Xience V drug-eluting stents. EuroIntervention. 2012 Oct;8(6):664-71. doi: 10.4244/EIJV8I6A104.
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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.
C. von Birgelen, MD,PhD,Prof principal investigator
Thorax Centrum Twente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Endeavor Resolute (Biolinx-based Zotarolimus-eluting stent) and Xience V (Everolimus-eluting stent) in people with Coronary Artery Disease and Angina Pectoris, run by Foundation of Cardiovascular Research and Education Enschede at 1 site in Netherlands.
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 3 inclusion and 8 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: finished, as of the sponsor's last update on 28 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
comparing target-vessel failure (TVF) of both stents (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 NCT01066650, 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 28 Jul 2015.