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Efficacy Study of Rapamycin- vs. Zotarolimus-Eluting Stents to Reduce Coronary Restenosis (ISAR-TEST-5)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00598533
Recruitment Status : Completed
First Posted : January 22, 2008
Last Update Posted : January 5, 2012
Information provided by (Responsible Party):
Deutsches Herzzentrum Muenchen

Brief Summary:
The purpose of this trial is to evaluate the efficacy of Rapamycin- and Zotarolimus-Eluting stents for the reduction of Coronary Restenosis

Condition or disease Intervention/treatment Phase
Coronary Heart Disease Device: Rapamycin + Probucol-eluting stent (ISAR stent) Device: polymer based Zotarolimus-eluting stent (Endeavor Resolute) Phase 4

Detailed Description:
This prospective, randomized trial will compare the efficacy and safety of a Rapamycin plus Probucol-eluting stent with a polymer based Zotarolimus-eluting stent. Patients with symptomatic coronary artery disease without cardiogenic shock who will undergo coronary angiography and willing to participate in the trial will receive a loading dose of 600mg clopidogrel at least 2 hours before the procedure. They will be randomized to receive one of the above mentioned stents.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3002 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prospective, Randomized Trial of Rapamycin- and Zotarolimus-eluting Stents for the Reduction of Coronary Restenosis
Study Start Date : February 2008
Actual Primary Completion Date : August 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Dual-DES
Rapamycin + Probucol-eluting stent
Device: Rapamycin + Probucol-eluting stent (ISAR stent)
due to randomization, Rapamycin- + Probucol-eluting stent will be implanted
Other Name: ISAR stent

Active Comparator: ZES
Polymer based Zotarolimus-eluting stent
Device: polymer based Zotarolimus-eluting stent (Endeavor Resolute)
due to randomization, Zotarolimus-eluting stent with polymer will be implanted
Other Name: Endeavor Resolute

Primary Outcome Measures :
  1. A composite endpoint of cardiac death, myocardial infarction related to the target vessel or target lesion revascularisation [ Time Frame: at one year ]

Secondary Outcome Measures :
  1. Late luminal loss [ Time Frame: at 6-8 months follow-up angiography ]
  2. stent thrombosis [ Time Frame: at one year ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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% de novo 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:

  • Target lesion located in the left main trunk.
  • Target lesion located in the bypass graft.
  • In-stent restenosis.
  • 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: Clopidogrel, Rapamycin, Probucol, Zotarolimus, stainless steel or cobalt chrome.
  • Inability to take clopidogrel 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 identifier (NCT number): NCT00598533

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Medizinische Klinik, Klinikum rechts der Isar
Muenchen, Germany, 81675
Deutsches Herzzentrum Muenchen
Munich, Germany, 80636
Sponsors and Collaborators
Deutsches Herzzentrum Muenchen
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Study Chair: Adnan Kastrati, MD Deutsches Herzzentrum Muenchen

Publications automatically indexed to this study by Identifier (NCT Number):

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Responsible Party: Deutsches Herzzentrum Muenchen Identifier: NCT00598533    
Other Study ID Numbers: GE IDE No. S02907
First Posted: January 22, 2008    Key Record Dates
Last Update Posted: January 5, 2012
Last Verified: January 2012
Additional relevant MeSH terms:
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Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Coronary Restenosis
Cardiovascular Diseases
Vascular Diseases
Arterial Occlusive Diseases
Coronary Stenosis
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Protective Agents