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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier:
NCT01230723
First received: October 28, 2010
Last updated: May 7, 2012
Last verified: May 2012
History of Changes
  Purpose

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 Intervention Phase
Coronary Heart Disease
 Device: Everolimus-Eluting-Stent
Device: Zotarolimus-Eluting-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 TRIAL OF ZOTAROLIMUS- AND EVEROLIMUS-ELUTING STENTS REGARDING STENT COVERAGE ASSESSED BY OCT

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Deutsches Herzzentrum Muenchen:

Primary Outcome Measures:
  • Degree of stent strut coverage assessed by OCT for each visible strut segment [ Time Frame: 6-8 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Percentage of malapposed strut assessed by OCT [ Time Frame: 6-8 months ] [ Designated as safety issue: Yes ]
  • Percentage of uncovered malapposed struts assessed by OCT [ Time Frame: 6-8 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: October 2010
Estimated Study Completion Date: July 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Zotarolimus-Eluting-Stent
 Device: Zotarolimus-Eluting-Stent
due randomization zotarolimus-eluting-stent will be implanted
Other Name: Endeavor Resolute®

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.

  Eligibility

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

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01230723

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

No publications provided

Responsible Party: Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier: NCT01230723     History of Changes
Other Study ID Numbers: GE IDE No. S03210
Study First Received: October 28, 2010
Last Updated: May 7, 2012
Health Authority: Germany: Ethics Commission

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

ClinicalTrials.gov processed this record on May 16, 2013