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
  Purpose

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).


Condition Intervention Phase
Coronary Artery Disease
Device: Bare metal stent implantation
Device: zotarolimus eluting stent
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Zotarolimus-eluting Endeavor Sprint Stent in Uncertain DES Candidates (ZEUS) Study

Resource links provided by NLM:


Further study details as provided by Università degli Studi di Ferrara:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Enrollment: 1606
Study Start Date: June 2011
Estimated Study Completion Date: December 2017
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: bare metal stent 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.

Experimental: Endeavor sprint stent 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.


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

  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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01385319

Locations
Hungary
Albert Szent-Györgyi Clinical Center, University of Szeged
Szeged, Hungary
Italy
Ospedale San Donato
Arezzo, AR, Italy, 52100
Ospedali Riuniti di Bergamo
Bergamo, BG, Italy, 24128
Policlinico San Marco
Zingonia, BG, Italy, 24040
Ospedale di Savigliano
Savigliano, CN, Italy, 12038
Istituto Clinico Sant'Ambrogio
Milano, MI, Italy, 20149
Azienda Unita' Sanitaria Locale Di Modena - Ospedale Baggiovara
Modena, MO, Italy, 41100
Azienda Ospedaliero-Universitaria di Parma
Parma, PR, Italy, 43126
Policlinico San Matteo
Pavia, PV, Italy, 27100
Ospedale di Ravenna
Ravenna, RA, Italy, 48121
Ospedale San Giovanni Bosco
Torino, TO, Italy, 10154
Azienda Ospedaliera Ordine Mauriziano di Torino, Ospedale Umberto I
Torino, TO, Italy, 10128
University Hospital of Ferrara
Ferrara, Italy, 44100
Clinica Mediterranea
Naples, Italy, 80122
Portugal
Hospital de Santa Cruz
Carnaxide, Portugal
Switzerland
University Hospital of Geneva
Geneva, Switzerland
Sponsors and Collaborators
Marco Valgimigli
  More Information

No publications provided by Università degli Studi di Ferrara

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Marco Valgimigli, Head of the Catheterization laboratory, Università degli Studi di Ferrara
ClinicalTrials.gov Identifier: NCT01385319     History of Changes
Other Study ID Numbers: ZEUS-10-II
Study First Received: June 24, 2011
Last Updated: October 6, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by Università degli Studi di Ferrara:
Bare metal stent
zotarolimus eluting stent
triple anti-thrombotic therapy
high bleeding riskduration of dual anti-platelet therapy

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014