Zotarolimus-eluting Endeavor Sprint Stent in Uncertain DES Candidates (ZEUS) Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Marco Valgimigli, Università degli Studi di Ferrara
ClinicalTrials.gov Identifier:
NCT01385319
First received: June 24, 2011
Last updated: October 6, 2012
Last verified: October 2012

June 24, 2011
October 6, 2012
June 2011
September 2012   (final data collection date for primary outcome measure)
MACE [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Major adverse cardiovascular events including death for any cause, non-fatal myocardial infarction or target vessel revascularisation
Same as current
Complete list of historical versions of study NCT01385319 on ClinicalTrials.gov Archive Site
  • Death [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • myocardial infarction [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • TVR [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    target vessel revascularisation
  • stent thrombosis [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Zotarolimus-eluting Endeavor Sprint Stent in Uncertain DES Candidates (ZEUS) Study
Zotarolimus-eluting Endeavor Sprint Stent in Uncertain DES Candidates (ZEUS) 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).

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

  1. Patients with coronary artery disease lesions at low risk of in-stent restenosis;
  2. Patients at high risk for bleeding or carrying impossibility to comply with dual anti-platelet treatment at long-term.
  3. 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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Coronary Artery Disease
  • Device: Bare metal stent implantation

    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.

  • Device: zotarolimus eluting stent

    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.

  • Active Comparator: bare metal stent
    Intervention: Device: Bare metal stent implantation
  • Experimental: Endeavor sprint stent
    Intervention: Device: zotarolimus eluting stent
Valgimigli 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1606
December 2017
September 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

A) 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

B) high bleeding risk and/or presence of relative-absolute contraindication to dual anti-platelet treatment beyond 30 days defined as follows:

  1. Clinical indication to treatment with oral anticoagulant, including use of warfarin or dabigatran or other oral anticoagulant agents
  2. Recent (within previous 12 months) bleeding episode(s) which required medical attention
  3. Previous bleeding episode(s) which required hospitalization if the bleeding diathesis has not been completely resolved (i.e. surgical removal of the bleeding source)
  4. Age greater than 80
  5. 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).
  6. Known Anemia defined as repeatedly documented hemoglobin lower than 10 gr/dl which is not due to an acute and documented blood loss
  7. Need for chronic treatment with steroids or NSAID

C) Patients at high thrombosis risk based on the presence of at least one of the following criteria:

  1. Allergy/intolerance to aspirin
  2. Allergy/intolerance to clopidogrel AND ticlopidine
  3. Planned surgery (other than skin) within 12 months of percutaneous coronary intervention (PCI).
  4. patient with cancers (other than skin) and life expectancy >1 year
  5. 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)

    -

    Exclusion Criteria:

    • Any of the following:

      1. 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.
      2. Subjects who are unable to give informed consent and assurance for complete contact through 12 months.
      3. PCI with stenting in the previous 6 months
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Hungary,   Italy,   Portugal,   Switzerland
 
NCT01385319
ZEUS-10-II
Yes
Marco Valgimigli, Università degli Studi di Ferrara
Marco Valgimigli
Not Provided
Not Provided
Università degli Studi di Ferrara
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP