Stent showdown: which Drug-Coated heart stent and blood thinner plan works best?
NCT ID NCT00698607
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested two different drug-coated stents (everolimus-eluting vs. sirolimus-eluting) in 1,466 people with narrowed heart arteries. It also compared taking the blood thinner clopidogrel for 6 months versus 12 months after stenting. The goal was to see which stent and which treatment duration better prevent artery re-narrowing and heart problems.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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1,466 people
The number who actually took part.
- Started
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Jun 2008
- Finished
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Apr 2014
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
General Inclusion Criteria: 1. Subject must be at least 18 years of age. 2. Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving the XIENCE V EECS and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure. 3. Subject must have significant coronary artery stenosis (\>50% by visual estimate) 4. Subject must have evidence of myocardial ischemia (e.g., stable, unstable angina, recent infarction, silent ischemia, positive functional study or a reversible changes in the electrocardiogram (ECG) consistent with ischemia. In subjects with coronary artery stenosis \> 75%, evidence of myocardial ischemia does not have to be documented. 5. Subjects must be an acceptable candidate for Coronary Artery Bypass Graft (CABG) surgery. Angiographically Inclusion Criteria 1. Target lesion(s) must be located in a native coronary artery with visually estimated diameter of ≥ 2.25 mm and ≤ 4.25 mm. 2. Target lesion(s) must be amenable for percutaneous coronary intervention General Exclusion Criteria: 1. The patient has a known hypersensitivity or contraindication to any of the following medications (heparin, aspirin, clopidogrel, sirolimus, everolimus, Contrast media 2. Systemic (intravenous) Sirolimus, everolimus use within 12 months. 3. Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study. 4. History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions. 5. Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months. 6. Current known current platelet count \<100,000 cells/mm3 or Hgb \<10 g/dL. 7. An elective surgical procedure is planned that would necessitate interruption of clopidogrel during the first 12 months post enrollment. 8. Non-cardiac co-morbid conditions are present with life expectancy \<1 year or that may result in protocol non-compliance (per site investigator's medical judgment). 9. Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period. 10. Patients who have received any stent implantation in the target vessel prior to enrollment. 11. Patients with LVEF\<25% or those with cardiogenic shock 12. Patients with myocardial infarction within 72 hours 13. Creatinine level ≥ 3.0mg/dL or dependence on dialysis. 14. Severe hepatic dysfunction (AST and ALT: 3 times upper normal reference values). Angiographic Exclusion Criteria 1. Patients with significant left main coronary artery stenosis 2. Patients who's target lesion has in-stent restenosis at the stented segment of drug-eluting stents or bare metal stents 3. Target lesions with chronic total occlusion 4. True bifurcation lesions requiring two stents
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Seoul National University Hospital
Seoul, 110-744, South Korea
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Other studies related to the condition(s) this trial covers.
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