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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.
Verified by Deutsches Herzzentrum Muenchen, March 2008

Sponsored by: Deutsches Herzzentrum Muenchen
Information provided by: Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier: NCT00598533
  Purpose

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


Condition Intervention Phase
Coronary Heart Disease
Device: rapamycin+probucol-eluting stent (ISAR stent)
Device: polymer based Zotarolimus-eluting stent (Endeavor Resolute)
Phase IV

MedlinePlus related topics:   Heart Diseases   

ChemIDplus related topics:   Sirolimus    Probucol   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:   Prospective, Randomized Trial of Rapamycin- and Zotarolimus-Eluting Stents for the Reduction of Coronary Restenosis

Further study details as provided by Deutsches Herzzentrum Muenchen:

Primary Outcome Measures:
  • 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 Measures:
  • 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 ]

Estimated Enrollment:   3000
Study Start Date:   February 2008
Estimated Study Completion Date:   December 2009
Estimated Primary Completion Date:   November 2009 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Active Comparator
rapamycin+probucol-eluting stent
Device: rapamycin+probucol-eluting stent (ISAR stent)
due to randomization, rapamycin- + Probucol-eluting stent will be implanted
2: Active Comparator
polymer based Zotarolimus-eluting stent
Device: polymer based Zotarolimus-eluting stent (Endeavor Resolute)
due to randomization, Zotarolimus-eluting stent with polymer will be implanted

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.

  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% 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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00598533

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    

Locations
Germany
Deutsches Herzzentrum Muenchen     Recruiting
      Munich, Germany, 80636
      Contact: Adnan Kastrati, MD     +49 89 1218-0 ext 4577     kastrati@dhm.mhn.de    
      Principal Investigator: Julinda Mehilli, MD            
Medizinische Klinik, Klinikum rechts der Isar     Recruiting
      Muenchen, Germany, 81675
      Contact: Josef Dirschinger, MD     +49 89 4140 2947        
      Principal Investigator: Josef Dirschinger, MD            

Sponsors and Collaborators
Deutsches Herzzentrum Muenchen

Investigators
Study Chair:     Albert Schoemig, MD     Deutsches Herzzentrum Muenchen    
  More Information

Responsible Party:   Deutsches Herzzentrum Munich ( Prof. A. Schömig )
Study ID Numbers:   GE IDE No. S02907
First Received:   January 10, 2008
Last Updated:   March 13, 2008
ClinicalTrials.gov Identifier:   NCT00598533
Health Authority:   Germany: German Institute of Medical Documentation and Information

Study placed in the following topic categories:
Sirolimus
Heart Diseases
Probucol
Clotrimazole
Myocardial Ischemia
Miconazole
Vascular Diseases
Tioconazole
Constriction, Pathologic
Ischemia
Coronary Restenosis
Coronary Stenosis
Coronary Disease

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Antioxidants
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antilipemic Agents
Physiological Effects of Drugs
Anticholesteremic Agents
Antibiotics, Antineoplastic
Immunosuppressive Agents
Protective Agents
Pharmacologic Actions
Anti-Bacterial Agents
Therapeutic Uses
Antifungal Agents
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 05, 2008




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