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

This study is currently recruiting participants.
Study NCT00598533.   Last updated on March 13, 2008.   Information provided by Deutsches Herzzentrum Muenchen

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Descriptive Information Fields
Brief Title  Efficacy Study of Rapamycin- and Zotarolimus-Eluting Stents to Reduce Coronary Restenosis
Official Title  Prospective, Randomized Trial of Rapamycin- and Zotarolimus-Eluting Stents for the Reduction of Coronary Restenosis
Brief Summary

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

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. Clinical follow-up will be performed at 30 days and one year.

Study Phase Phase IV
Study Type  Interventional
Study Design  Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary Outcome Measure  A composite endpoint of cardiac death, myocardial infarction related to the target vessel or target lesion revascularisation [ Time Frame: at one year ] [ Designated as safety issue: No ]
Secondary Outcome Measure  Late luminal loss [ Time Frame: at 6-8 months follow-up angiography ] [ Designated as safety issue: No ]
stent thrombosis [ Time Frame: at one year ] [ Designated as safety issue: Yes ]
Condition  Coronary Heart Disease
Intervention  Device: rapamycin+probucol-eluting stent (ISAR stent)
Device: polymer based Zotarolimus-eluting stent (Endeavor Resolute)
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  3000
Start Date  February 2008
Completion Date December 2009
Eligibility Criteria 

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.
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Contact: Adnan Kastrati, MD     +49 89 12 18-0 ext 4577     kastrati@dhm.mhn.de    
Contact: Julinda Mehilli, MD     +49 89 12 18-0 ext 4582     mehilli@dhm.mhn.de    
Location Countries  Germany
Administrative Information Fields
NCT ID  NCT00598533
Organization ID GE IDE No. S02907
Secondary IDs ††
Study Sponsor  Deutsches Herzzentrum Muenchen
Collaborators ††
Investigators 
Study Chair:     Albert Schoemig, MD     Deutsches Herzzentrum Muenchen    
Information Provided By Deutsches Herzzentrum Muenchen
Verification Date March 2008
First Received Date  January 10, 2008
Last Updated Date March 13, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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