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

Phase 4

Completed

• Conditions: Coronary Heart Disease
• Interventions: Device: Rapamycin + Probucol-eluting stent (ISAR stent); Device: polymer based Zotarolimus-eluting stent (Endeavor Resolute)

• Registration Number: NCT00598533
• Lead Sponsor: Deutsches Herzzentrum Muenchen

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.

Study Timeline

• Study First Submitted: 2008-01-10
• Study First Submitted QC: 2008-01-21
• Study First Posted: 2008-01-22
• Study Start: 2008-02
• Primary Completion: 2010-08
• Study Completion: 2010-09
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-03
• Last Update Posted: 2012-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3002

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dual-DES	Rapamycin + Probucol-eluting stent (ISAR stent)	Rapamycin + Probucol-eluting stent
ZES	polymer based Zotarolimus-eluting stent (Endeavor Resolute)	Polymer based Zotarolimus-eluting stent

Primary Outcome Measures

Name	Time	Method
A composite endpoint of cardiac death, myocardial infarction related to the target vessel or target lesion revascularisation	at one year

Secondary Outcome Measures

Name	Time	Method
Late luminal loss	at 6-8 months follow-up angiography
stent thrombosis	at one year

Trial Locations

Locations (2)

Medizinische Klinik, Klinikum rechts der Isar; 🇩🇪 Muenchen, Germany

Deutsches Herzzentrum Muenchen; 🇩🇪 Munich, Germany