Zotarolimus and Everolimus-Eluting Stents ProsPectively Compared in Real World (ZEPPELIN)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by Deutsches Herzzentrum Muenchen.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier:
NCT00768846
First received: October 6, 2008
Last updated: October 11, 2008
Last verified: October 2008
  Purpose

The zotarolimus-eluting Endeavor Resolute stent is not inferior to the everolimus- eluting Xience V stent platform regarding a composite of cardiac death, myocardial infarction or target lesion revascularisation in a real-world population.


Condition Intervention Phase
Coronary Artery Disease
Device: Endeavor Resolute Stent
Device: Xience V Stent
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Comparison of Zotarolimus- and Everolimus-Eluting Stents for Coronary Treatment

Resource links provided by NLM:


Further study details as provided by Deutsches Herzzentrum Muenchen:

Primary Outcome Measures:
  • A composite of cardiac death, myocardial infarction related to the target vessel or target lesion revascularisation [ Time Frame: 1 year after randomization ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Late luminal loss [ Time Frame: 6-8 months ] [ Designated as safety issue: No ]
  • Binary angiographic restenosis [ Time Frame: 6-8 months ] [ Designated as safety issue: No ]
  • All cause mortality [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Stent thrombosis [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 2600
Study Start Date: September 2008
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Endeavor Resolute Stent
Device: Endeavor Resolute Stent
Zotarolimus-eluting Endeavor Resolute Stent
Active Comparator: 2
Xience V Stent
Device: Xience V Stent
Everolimus-eluting Xience V Stent

Detailed Description:

The use of stents has become common practice in the percutaneous treatment of coronary artery disease. Restenosis affected 20-40% of de novo coronary lesions treated with bare metal stents. Drug-eluting stents (DES) have emerged as the most effective strategy for the prevention of restenosis. The first available DES were the Sirolimus-eluting Cypher and the Paclitaxel-eluting Taxus stent. Although their mid-term efficacy has been well-established, there is an ongoing debate on the potential of an increased incidence of late stent thrombosis, as well as of delayed onset of restenosis or catch-up phenomenon with DES. Recent evidence demonstrates that there might be differences between various DES in terms of safety and efficacy. The differences might be related to the drug, polymer or stent design. Everolimus (SDZ-RAD) and zotarolimus (ABT-578) are new antiproliferative agents that share some common structural and biological properties with sirolimus ("limus-group"). Both drugs bind to the intracellular sirolimus receptor, FK 506-binding protein 12 (FKBP 12). The drug-FKBP12 complex inhibits cell cycle progression via inactivation of the mammalian target of Rapamycin (mTOR) thereby regulating vascular smooth muscle cell migration and proliferation. Preclinical studies showed improved endothelialization and limited chronic inflammation of the everolimus-eluting stent compared with previous drug-eluting stents. Moreover, first randomized clinical trials of everolimus-eluting stents have shown promising results regarding safety, feasibility and efficacy in the suppression of neointimal proliferation. Safety and efficacy of the zotarolimus-eluting Endeavor stent have been investigated in the Endeavor clinical program. In the Endeavor III and IV trials, the Endeavour stent proved inferior to the Cypher and Taxus stents regarding angiographic endpoints. However, rates of target vessel failure were similar in both groups. The Endeavor RESOLUTE stent platform uses a new polymer with potential improvements of drug release compared to the Endeavor stent. The RESOLUTE clinical trial is the first-in man, observational, uncontrolled, non-randomized study evaluating the Endeavor Resolute drug-eluting stent with the new polymer. The trial enrolled a total of 130 patients with native coronary artery lesions. There are no data available comparing the zotarolimus-eluting Endeavor Resolute stent with the everolimus-eluting Xience V stent. Thus the aim of this prospective, randomized study is to compare the efficacy and safety of these two "new generation" drug-eluting stent platforms in a real world population.

  Eligibility

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

Inclusion Criteria:

  • Patients older than 18 years with symptomatic coronary artery disease undergoing PCI with stent implantation.
  • Written, informed consent by the patient or her/his legally-authorized representative for participation in the study.

Exclusion Criteria:

  • Cardiogenic shock.
  • Malignancies or other comorbid conditions (for example severe liver, renal and pancreatic disease) with life expectancy less than 12 months or that may result in protocol non-compliance.
  • Known allergy to the study medications: everolimus, zotarolimus, cobalt chrome.
  • Inability to take clopidogrel for at least 6 months.
  • Pregnancy (present, suspected or planned) or positive pregnancy test. (In women with childbearing potential a pregnancy test is mandatory.)
  • Previous enrollment in this trial.
  • Patient's inability to fully cooperate with the study protocol.
  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: NCT00768846

Contacts
Contact: Julinda Mehilli, MD +49-1218 ext 4582 mehilli@dhm.mhn.de
Contact: Stefanie Schulz, MD +49-1218 ext 1521 schulzs@dhm.mhn.de

Locations
Germany
1st Medizinische Klinik Klinikum rechts der Isar Recruiting
Munich, Germany, 81675
Contact: Josef Dirschinger, MD    +49-4140 ext 2947    dirschinger@med1.med.tum.de   
Deutsches Herzzentrum Munich Recruiting
Munich, Germany, 81675
Contact: Julinda Mehilli, MD    +49-1218- ext 4582    mehilli@dhm.mhn.de   
Contact: Stefanie Schulz, MD    +49-1218- ext 1521    schulzs@dhm.mhn.de   
Sponsors and Collaborators
Deutsches Herzzentrum Muenchen
Investigators
Study Chair: Adnan Kastrati, MD Deutsches Herzzentrum Munich
Principal Investigator: Julinda Mehilli, MD Deutsches Herzzentrum Munich
  More Information

No publications provided

Responsible Party: Prof. Dr. A. Schoemig, Klinik fuer Herz- und Kreislauferkrankungen, Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier: NCT00768846     History of Changes
Other Study ID Numbers: GE IDE No. S03008
Study First Received: October 6, 2008
Last Updated: October 11, 2008
Health Authority: Germany: German Institute of Medical Documentation and Information

Keywords provided by Deutsches Herzzentrum Muenchen:
PCI
Stent
DES
CAD

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases
Everolimus
Sirolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014