Coronary Artery DiseasePhase 3ZEUSNCT01385319
Zotarolimus-eluting Endeavor Sprint Stent in Uncertain DES Candidates (ZEUS) Study
A Phase 3 study testing Bare metal stent implantation and zotarolimus eluting stent in people with Coronary Artery Disease, run by Marco Valgimigli at 16 sites in 4 countries.
Trial summary
To prospectively evaluate in a multicenter open label trial whether the use of zotarolimus-eluting ENDEAVOR Stent implantation in patients at low restenosis or at high bleeding or thrombotic risk will decrease the incidence of 12-month major adverse cardiac events (MACE) including overall death, any myocardial… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Bare metal stent implantation and zotarolimus eluting stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,606 participants
- Where
- 16 sitesin 4 countries
- Study dates
- Jun 2011to Dec 2017
- Phase
- Phase 3
- 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
- low restenosis risk based on angiographic findings defined as follows:
- ----patients will be considered at low restenosis risk if no planned stent lower than 3.0 mm is intended to be implanted in lesions expect left main or vein graft
- high bleeding risk and/or presence of relative-absolute contraindication to dual anti-platelet treatment beyond 30 days defined as follows:
- Clinical indication to treatment with oral anticoagulant, including use of warfarin or dabigatran or other oral anticoagulant agents
- Recent (within previous 12 months) bleeding episode(s) which required medical attention
- Previous bleeding episode(s) which required hospitalization if the bleeding diathesis has not been completely resolved (i.e. surgical removal of the bleeding source)
Show all 17Show fewer
- Age greater than 80
- Systemic conditions associated to increased bleeding risk (e.g. hematological disorders or any known coagulopathy determining bleeding diathesis, including history of or current thrombocytopenia defined as platelet count <100,000/mm3 (<100 x 109/L).
- Known Anemia defined as repeatedly documented hemoglobin lower than 10 gr/dl which is not due to an acute and documented blood loss
- Need for chronic treatment with steroids or NSAID
- Patients at high thrombosis risk based on the presence of at least one of the following criteria:
- Allergy/intolerance to aspirin
- Allergy/intolerance to clopidogrel AND ticlopidine
- Planned surgery (other than skin) within 12 months of percutaneous coronary intervention (PCI).
- patient with cancers (other than skin) and life expectancy >1 year
- Patients with systemic conditions associated with thrombosis diathesis (e.g., hematologic disorders and any known systemic conditions determining a pro-thrombotic state including immunological disorders)
- -
Who cannot join
- Any of the following:
- Women who are pregnant. Women of childbearing potential must have a negative pregnancy test (urine or serum HCG) within 7 days prior to randomization; as close to randomization as possible, within 24 hours preferred.
- Subjects who are unable to give informed consent and assurance for complete contact through 12 months.
- PCI with stenting in the previous 6 months
Trial locations and contacts
16 sites in 4 countries.
16 sites in 4 countries
Italy13 sites
Ospedale San Donato
Arezzo, AR, 52100
Ospedali Riuniti di Bergamo
Bergamo, BG, 24128
University Hospital of Ferrara
Ferrara, 44100
Istituto Clinico Sant'Ambrogio
Milan, MI, 20149
Azienda Unita' Sanitaria Locale Di Modena - Ospedale Baggiovara
Modena, MO, 41100
Clinica Mediterranea
Naples, 80122
Azienda Ospedaliero-Universitaria di Parma
Parma, PR, 43126
Policlinico San Matteo
Pavia, PV, 27100
Ospedale di Ravenna
Ravenna, RA, 48121
Ospedale di Savigliano
Savigliano, CN, 12038
Azienda Ospedaliera Ordine Mauriziano di Torino, Ospedale Umberto I
Torino, TO, 10128
Ospedale San Giovanni Bosco
Torino, TO, 10154
Policlinico San Marco
Zingonia, BG, 24040
Hungary1 site
Albert Szent-Györgyi Clinical Center, University of Szeged
Szeged
About this study
To prospectively evaluate in a multicenter open label trial whether the use of zotarolimus-eluting ENDEAVOR Stent implantation in patients at low restenosis or at high bleeding or thrombotic risk will decrease the incidence of 12-month major adverse cardiac events (MACE) including overall death, any myocardial infarction (MI) or any target vessel revascularization (TVR).
Read the detailed description
The aim of this study is to conduct a multicenter, international, randomized trial to test whether the Endeavor stent is superior to BMS in terms of efficacy and safety in
- Patients with coronary artery disease lesions at low risk of in-stent restenosis;
- Patients at high risk for bleeding or carrying impossibility to comply with dual anti-platelet treatment at long-term.
- Patients at high thrombosis risk due to systemic disorders or planned non-cardiac surgery within 12 months
As the use of DES in these two patient/lesion subsets is debated due to lack of evidence, patients fulfilling at least one of these three medical conditions qualify for bare metal stent implantation and physicians may believe DES to be even contra-indicated in such cases. The current protocol has been developed on purpose to address the value of the Endeavor Sprint stent, which differs in many aspects from other FDA approved DES, including fast and complete degree of strut coverage after implantation and quick release of active drug after deployment (~15 days) which may help decreasing the need for prolonged dual antiplatelet treatment down to 1 month as it is currently recommended for bare metal stent implantation.
- Conditions
- Coronary Artery Disease
- Being tested
- Bare metal stent implantation, zotarolimus eluting stent
- Keywords
- Bare metal stent, zotarolimus eluting stent, triple anti-thrombotic therapy, high bleeding riskduration of dual anti-platelet therapy
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bare metal stent implantationDevice
After BMS implantation the duration of dual anti-platelet therapy is a function of the clinical presentation and the bleeding risk a given patient as follows:
Clopidogrel will be given for 1 month after PCI if indication to the procedure is stable coronary artery disease or for at least 6 month if indication to the procedure is ACS, including STEMI or NSTEACS. At discretion of the treating physician, prasugrel or ticagrelor may replace clopidogrel in ACS patients.
Patients recruited in the study due to high bleeding risk will receive clopidogrel for at least 30 days.
Patients recruited in the study due to high thrombosis risk will receive clopidogrel monotherapy life long or DAPT for at least 1 month.
zotarolimus eluting stentDevice
After ZES implantation the duration of dual anti-platelet therapy is a function of the clinical presentation and the bleeding risk a given patient (i.e. identical to criteria set out for BMS patients) as follows:
Clopidogrel will be given for 1 month after PCI if indication to the procedure is stable coronary artery disease or for at least 6 month if indication to the procedure is ACS, including STEMI or NSTEACS. At discretion of the treating physician, prasugrel or ticagrelor may replace clopidogrel in ACS patients.
Patients recruited in the study due to high bleeding risk will receive clopidogrel for at least 30 days.
Patients recruited in the study due to high thrombosis risk will receive clopidogrel monotherapy life long or DAPT for at least 1 month.
| Study group | Role | What they receive |
|---|---|---|
| bare metal stent | Active comparator | Not described Receives: Device: Bare metal stent implantation |
| Endeavor sprint stent | Experimental | Not described Receives: Device: zotarolimus eluting stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
MACE
Major adverse cardiovascular events including death for any cause, non-fatal myocardial infarction or target vessel revascularisation
Measured: 12 months
Secondary outcomes (4)
Death
Measured: 12 months
myocardial infarction
Measured: 12 months
TVR
target vessel revascularisation
Measured: 12 months
stent thrombosis
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionSep 2012
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,606 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marco Valgimigli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marco Valgimigli, Università degli Studi di Ferrara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01385319
- Sponsor's protocol ID
- ZEUS-10-II
- Acronym
- ZEUS
- Status last verified
- Oct 2012
- First submitted
- 24 Jun 2011
- Last updated
- 10 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ariotti S, Adamo M, Costa F, Patialiakas A, Briguori C, Thury A, Colangelo S, Campo G, Tebaldi M, Ungi I, Tondi S, Roffi M, Menozzi A, de Cesare N, Garbo R, Meliga E, Testa L, Gabriel HM, Ferlini M, Vranckx P, Valgimigli M; ZEUS Investigators. Is Bare-Metal Stent Implantation Still Justifiable in High Bleeding Risk Patients Undergoing Percutaneous Coronary Intervention?: A Pre-Specified Analysis From the ZEUS Trial. JACC Cardiovasc Interv. 2016 Mar 14;9(5):426-36. doi: 10.1016/j.jcin.2015.11.015.
PubMed 26965932Valgimigli M, Patialiakas A, Thury A, McFadden E, Colangelo S, Campo G, Tebaldi M, Ungi I, Tondi S, Roffi M, Menozzi A, de Cesare N, Garbo R, Meliga E, Testa L, Gabriel HM, Airoldi F, Ferlini M, Liistro F, Dellavalle A, Vranckx P, Briguori C; ZEUS Investigators. Zotarolimus-eluting versus bare-metal stents in uncertain drug-eluting stent candidates. J Am Coll Cardiol. 2015 Mar 3;65(8):805-815. doi: 10.1016/j.jacc.2014.11.053.
PubMed 25720624Valgimigli M, Patialiakas A, Thury A, Colangelo S, Campo G, Tebaldi M, Ungi I, Tondi S, Roffi M, Menozzi A, de Cesare N, Garbo R, Meliga E, Testa L, Gabriel HM, Airoldi F, Ferlini M, Liistro F, Dellavalle A, Vranckx P, Briguori C. Randomized comparison of Zotarolimus-Eluting Endeavor Sprint versus bare-metal stent implantation in uncertain drug-eluting stent candidates: rationale, design, and characterization of the patient population for the Zotarolimus-eluting Endeavor Sprint stent in uncertain DES candidates study. Am Heart J. 2013 Nov;166(5):831-8. doi: 10.1016/j.ahj.2013.07.033. Epub 2013 Sep 26.
PubMed 24176438
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zotarolimus-eluting Endeavor Sprint Stent in Uncertain DES Candidates (ZEUS) Study
- ClinicalTrials.gov ID
- NCT01385319
- Acronym / sponsor ID
- ZEUS / ZEUS-10-II
- Conditions
- Coronary Artery Disease
- Keywords
- Bare metal stent, zotarolimus eluting stent, triple anti-thrombotic therapy, high bleeding riskduration of dual anti-platelet therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,606 participants (actual)
- Lead sponsor
- Marco ValgimigliUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Dec 2017 (estimated)
- First posted
- 30 Jun 2011 (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.
To prospectively evaluate in a multicenter open label trial whether the use of zotarolimus-eluting ENDEAVOR Stent implantation in patients at low restenosis or at high bleeding or thrombotic risk will decrease the incidence of 12-month major adverse cardiac events (MACE) including overall death, any myocardial infarction (MI) or any target vessel revascularization (TVR).
Detailed description
The aim of this study is to conduct a multicenter, international, randomized trial to test whether the Endeavor stent is superior to BMS in terms of efficacy and safety in
- Patients with coronary artery disease lesions at low risk of in-stent restenosis;
- Patients at high risk for bleeding or carrying impossibility to comply with dual anti-platelet treatment at long-term.
- Patients at high thrombosis risk due to systemic disorders or planned non-cardiac surgery within 12 months
As the use of DES in these two patient/lesion subsets is debated due to lack of evidence, patients fulfilling at least one of these three medical conditions qualify for bare metal stent implantation and physicians may believe DES to be even contra-indicated in such cases. The current protocol has been developed on purpose to address the value of the Endeavor Sprint stent, which differs in many aspects from other FDA approved DES, including fast and complete degree of strut coverage after implantation and quick release of active drug after deployment (~15 days) which may help decreasing the need for prolonged dual antiplatelet treatment down to 1 month as it is currently recommended for bare metal stent implantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bare metal stent | Active comparator | Device: Bare metal stent implantation |
| Endeavor sprint stent | Experimental | Device: zotarolimus eluting stent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- low restenosis risk based on angiographic findings defined as follows:
- ----patients will be considered at low restenosis risk if no planned stent lower than 3.0 mm is intended to be implanted in lesions expect left main or vein graft
- high bleeding risk and/or presence of relative-absolute contraindication to dual anti-platelet treatment beyond 30 days defined as follows:
- Clinical indication to treatment with oral anticoagulant, including use of warfarin or dabigatran or other oral anticoagulant agents
- Recent (within previous 12 months) bleeding episode(s) which required medical attention
Key exclusion criteria (4 listed)
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 |
|---|---|---|
| Bare metal stent implantationAfter BMS implantation the duration of dual anti-platelet therapy is a function of the clinical presentation and the bleeding risk a given patient as follows: Clopidogrel will be given for 1 month after PCI if indication to the procedure is stable coronary artery disease or for at least 6 month if indication to the procedure is ACS, including STEMI or NSTEACS. At discretion of the treating physician, prasugrel or ticagrelor may replace clopidogrel in ACS patients. Patients recruited in the study due to high bleeding risk will receive clopidogrel for at least 30 days. Patients recruited in the study due to high thrombosis risk will receive clopidogrel monotherapy life long or DAPT for at least 1 month. | Device | bare metal stent |
| zotarolimus eluting stentAfter ZES implantation the duration of dual anti-platelet therapy is a function of the clinical presentation and the bleeding risk a given patient (i.e. identical to criteria set out for BMS patients) as follows: Clopidogrel will be given for 1 month after PCI if indication to the procedure is stable coronary artery disease or for at least 6 month if indication to the procedure is ACS, including STEMI or NSTEACS. At discretion of the treating physician, prasugrel or ticagrelor may replace clopidogrel in ACS patients. Patients recruited in the study due to high bleeding risk will receive clopidogrel for at least 30 days. Patients recruited in the study due to high thrombosis risk will receive clopidogrel monotherapy life long or DAPT for at least 1 month. | Device | Endeavor sprint stent |
Primary outcome
MACE
Time frame: 12 months
Major adverse cardiovascular events including death for any cause, non-fatal myocardial infarction or target vessel revascularisation
4 secondary outcomes
Death
Time frame: 12 months
myocardial infarction
Time frame: 12 months
TVR
Time frame: 12 months
stent thrombosis
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2012.
- Derived from this study: PubMed 26965932Ariotti S, Adamo M, Costa F, Patialiakas A, Briguori C, Thury A, Colangelo S, Campo G, Tebaldi M, Ungi I, Tondi S, Roffi M, Menozzi A, de Cesare N, Garbo R, Meliga E, Testa L, Gabriel HM, Ferlini M, Vranckx P, Valgimigli M; ZEUS Investigators. Is Bare-Metal Stent Implantation Still Justifiable in High Bleeding Risk Patients Undergoing Percutaneous Coronary Intervention?: A Pre-Specified Analysis From the ZEUS Trial. JACC Cardiovasc Interv. 2016 Mar 14;9(5):426-36. doi: 10.1016/j.jcin.2015.11.015.
- Derived from this study: PubMed 25720624Valgimigli M, Patialiakas A, Thury A, McFadden E, Colangelo S, Campo G, Tebaldi M, Ungi I, Tondi S, Roffi M, Menozzi A, de Cesare N, Garbo R, Meliga E, Testa L, Gabriel HM, Airoldi F, Ferlini M, Liistro F, Dellavalle A, Vranckx P, Briguori C; ZEUS Investigators. Zotarolimus-eluting versus bare-metal stents in uncertain drug-eluting stent candidates. J Am Coll Cardiol. 2015 Mar 3;65(8):805-815. doi: 10.1016/j.jacc.2014.11.053.
- Derived from this study: PubMed 24176438Valgimigli M, Patialiakas A, Thury A, Colangelo S, Campo G, Tebaldi M, Ungi I, Tondi S, Roffi M, Menozzi A, de Cesare N, Garbo R, Meliga E, Testa L, Gabriel HM, Airoldi F, Ferlini M, Liistro F, Dellavalle A, Vranckx P, Briguori C. Randomized comparison of Zotarolimus-Eluting Endeavor Sprint versus bare-metal stent implantation in uncertain drug-eluting stent candidates: rationale, design, and characterization of the patient population for the Zotarolimus-eluting Endeavor Sprint stent in uncertain DES candidates study. Am Heart J. 2013 Nov;166(5):831-8. doi: 10.1016/j.ahj.2013.07.033. Epub 2013 Sep 26.
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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.
The record lists no contact. Use the official record to reach the sponsor.
16 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bare metal stent implantation and zotarolimus eluting stent in people with Coronary Artery Disease, run by Marco Valgimigli at 16 sites in 4 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 17 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 10 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Italy, Hungary, Portugal, Switzerland. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
MACE (time frame: 12 months). 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 NCT01385319, which also lists 3 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 10 Oct 2012.