Prospective, Randomized Trial of Rapamycin- and Zotarolimus-eluting Stents for the Reduction of Coronary Restenosis
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Coronary Heart Disease
- Sponsor
- Deutsches Herzzentrum Muenchen
- Enrollment
- 3002
- Locations
- 2
- Primary Endpoint
- A composite endpoint of cardiac death, myocardial infarction related to the target vessel or target lesion revascularisation
- Status
- Completed
- Last Updated
- 14 years ago
Overview
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.
Investigators
Eligibility 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.
Outcomes
Primary Outcomes
A composite endpoint of cardiac death, myocardial infarction related to the target vessel or target lesion revascularisation
Time Frame: at one year
Secondary Outcomes
- Late luminal loss(at 6-8 months follow-up angiography)
- stent thrombosis(at one year)