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

• 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 ]

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

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.

• Device: Rapamycin + Probucol-eluting stent (ISAR stent)
  due to randomization, Rapamycin- + Probucol-eluting stent will be implanted
  Other Name: ISAR stent
• Device: polymer based Zotarolimus-eluting stent (Endeavor Resolute)
  due to randomization, Zotarolimus-eluting stent with polymer will be implanted
  Other Name: Endeavor Resolute

• Experimental: Dual-DES
  Rapamycin + Probucol-eluting stent
  Intervention: Device: Rapamycin + Probucol-eluting stent (ISAR stent)
• Active Comparator: ZES
  Polymer based Zotarolimus-eluting stent
  Intervention: Device: polymer based Zotarolimus-eluting stent (Endeavor Resolute)

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.