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Test Safety and Efficacy of Zotarolimus- and Everolimus-Eluting Stents (ZES/EES) Assessed by Optical Coherence Tomography (ZES/EES-OCT)

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ClinicalTrials.gov Identifier: NCT01230723
Recruitment Status : Unknown
Verified May 2012 by Deutsches Herzzentrum Muenchen.
Recruitment status was:  Active, not recruiting
First Posted : October 29, 2010
Last Update Posted : May 8, 2012
Information provided by (Responsible Party):
Deutsches Herzzentrum Muenchen

Brief Summary:
The objective of the study is to assess the superiority of the everolimus-eluting stent (Endeavor Resolute®) compared with the everolimus-eluting stent (XIENCE V®) regarding uncovered stent strut segments.

Condition or disease Intervention/treatment Phase
Coronary Heart Disease Device: Everolimus-Eluting-Stent Device: Zotarolimus-Eluting-Stent Phase 4

Detailed Description:
The mid-term efficacy of drug-eluting stents has been well-established, but there is an ongoing debate on the potential of an increased incidence of late stent thrombosis, particularly after discontinuation of thienopyridine therapy, as well as of delayed onset of restenosis or catch-up phenomenon with permanent polymer-based DES. The extent of strut coverage with reduction of exposed thrombogenic material has been shown to be associated with the inflammatory reaction grade and with the incidence of stent thrombosis. The optical coherence tomography (OCT) is an intravascular imaging modality based on light. The principle is similar to intravascular ultrasound, but due to the much shorter wave length of light, it offers a much better resolution up to 10µm, enabling the exact determination of strut coverage, neointimal thickness, vessel size, presence of dissections, and even the presence of inflammation.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : October 2010
Primary Completion Date : December 2011
Estimated Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Arm 1
Everolimus-Eluting Stent
Device: Everolimus-Eluting-Stent
due randomization everolimus-eluting-stent will be implanted
Other Name: Xience-V®
Active Comparator: Arm 2
Device: Zotarolimus-Eluting-Stent
due randomization zotarolimus-eluting-stent will be implanted
Other Name: Endeavor Resolute®

Primary Outcome Measures :
  1. Degree of stent strut coverage assessed by OCT for each visible strut segment [ Time Frame: 6-8 months ]

Secondary Outcome Measures :
  1. Percentage of malapposed strut assessed by OCT [ Time Frame: 6-8 months ]
  2. Percentage of uncovered malapposed struts assessed by OCT [ Time Frame: 6-8 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients older than age 18 with ischemic symptoms or evidence of myocardial ischemia in the presence of ≥ 50% stenosis located in native coronary vessels.
  • Written, informed consent by the patient or her/his legally-authorized representative for participation in the study.
  • In women with childbearing potential a negative pregnancy test is mandatory.

Exclusion Criteria:

  • Lesion length >16mm requiring a stent length >18mm
  • Target lesion located in the left main trunk.
  • In-stent restenosis.
  • Acute myocardial infarction
  • 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, stainless steel or cobalt chrome.
  • Inability to take dual antiplatelet therapy for at least 6 months.
  • Pregnancy (present, suspected or planned) or positive pregnancy test.
  • Previous enrollment in this trial.
  • Patient's inability to fully cooperate with the study protocol.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01230723

Deutsches Herzzentrum Muenchen
Munich, Bavaria, Germany, 80636
Klinikum rechts der Isar
Munich, Bavaria, Germany, 81675
Sponsors and Collaborators
Deutsches Herzzentrum Muenchen
Principal Investigator: Klaus Tiroch, MD Deutsches Herzzentrum Muenchen

Responsible Party: Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier: NCT01230723     History of Changes
Other Study ID Numbers: GE IDE No. S03210
First Posted: October 29, 2010    Key Record Dates
Last Update Posted: May 8, 2012
Last Verified: May 2012

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