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Zotarolimus and Everolimus-Eluting Stents ProsPectively Compared in Real World

NCT ID: NCT00768846

Last Updated: 2008-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

2600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2011-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Coronary Artery Disease

Keywords

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PCI Stent DES CAD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Endeavor Resolute Stent

Group Type ACTIVE_COMPARATOR

Endeavor Resolute Stent

Intervention Type DEVICE

Zotarolimus-eluting Endeavor Resolute Stent

2

Xience V Stent

Group Type ACTIVE_COMPARATOR

Xience V Stent

Intervention Type DEVICE

Everolimus-eluting Xience V Stent

Interventions

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Endeavor Resolute Stent

Zotarolimus-eluting Endeavor Resolute Stent

Intervention Type DEVICE

Xience V Stent

Everolimus-eluting Xience V Stent

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Deutsches Herzzentrum Muenchen

OTHER

Sponsor Role lead

Responsible Party

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Klinik fuer Herz- und Kreislauferkrankungen, Deutsches Herzzentrum Muenchen

Principal Investigators

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Adnan Kastrati, MD

Role: STUDY_CHAIR

Deutsches Herzzentrum Munich

Julinda Mehilli, MD

Role: PRINCIPAL_INVESTIGATOR

Deutsches Herzzentrum Munich

Locations

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1st Medizinische Klinik Klinikum rechts der Isar

Munich, , Germany

Site Status RECRUITING

Deutsches Herzzentrum Munich

Munich, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Julinda Mehilli, MD

Role: CONTACT

Phone: +49-1218

Email: [email protected]

Stefanie Schulz, MD

Role: CONTACT

Phone: +49-1218

Email: [email protected]

Facility Contacts

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Josef Dirschinger, MD

Role: primary

Julinda Mehilli, MD

Role: primary

Stefanie Schulz, MD

Role: backup

Other Identifiers

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GE IDE No. S03008

Identifier Type: -

Identifier Source: org_study_id