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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 |
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| 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. |
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| 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 ] |
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| Condition † | Coronary Heart Disease | ||||||||
| Intervention † | Device: rapamycin+probucol-eluting stent (ISAR stent) Device: polymer based Zotarolimus-eluting stent (Endeavor Resolute) |
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| MEDLINE PMIDs | |||||||||
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| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 3000 | ||||||||
| Start Date † | February 2008 | ||||||||
| Completion Date | December 2009 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
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| Location Countries † | Germany | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00598533 | ||||||||
| Organization ID | GE IDE No. S02907 | ||||||||
| Secondary IDs †† | |||||||||
| Study Sponsor † | Deutsches Herzzentrum Muenchen | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
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| Information Provided By | Deutsches Herzzentrum Muenchen | ||||||||
| Verification Date | March 2008 | ||||||||
| First Received Date † | January 10, 2008 | ||||||||
| Last Updated Date | March 13, 2008 | ||||||||