Efficacy Study of Rapamycin- vs. Zotarolimus-Eluting Stents to Reduce Coronary Restenosis

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

Detailed Description
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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.

Official Title
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Prospective, Randomized Trial of Rapamycin- and Zotarolimus-eluting Stents for the Reduction of Coronary Restenosis

Conditions
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Coronary Heart Disease

Intervention / Treatment
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* Device: Rapamycin + Probucol-eluting stent (ISAR stent)
* Device: polymer based Zotarolimus-eluting stent (Endeavor Resolute)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dual-DES<br>Rapamycin + Probucol-eluting stent | Device: Rapamycin + Probucol-eluting stent (ISAR stent)<br>* due to randomization, Rapamycin- + Probucol-eluting stent will be implanted<br>* Other names: ISAR stent;|
| Active Comparator: ZES<br>Polymer based Zotarolimus-eluting stent | Device: polymer based Zotarolimus-eluting stent (Endeavor Resolute)<br>* due to randomization, Zotarolimus-eluting stent with polymer will be implanted<br>* Other names: Endeavor Resolute;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A composite endpoint of cardiac death, myocardial infarction related to the target vessel or target lesion revascularisation |  | at one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Late luminal loss |  | at 6-8 months follow-up angiography | 
| stent thrombosis |  | at one year |