Status:
UNKNOWN
Efficacy of Xience/Promus Versus Cypher in rEducing Late Loss After stENTing
Lead Sponsor:
Seoul National University Hospital
Collaborating Sponsors:
Abbott
Boston Scientific Corporation
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Objectives 1. To evaluate the safety and long-term effectiveness of coronary stenting with the Everolimus-eluting coronary stent system(EECSS) (XIENCETM V, Abbott Vascular, Santa Clara, CA, PromusTM,...
Eligibility Criteria
Inclusion
- General
- Subject must be at least 18 years of age.
- 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.
- Subject must have significant coronary artery stenosis (\>50% by visual estimate)
- 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.
- Subjects must be an acceptable candidate for Coronary Artery Bypass Graft (CABG) surgery.
- Angiographically Inclusion Criteria
- Target lesion(s) must be located in a native coronary artery with visually estimated diameter of ≥ 2.25 mm and ≤ 4.25 mm.
- Target lesion(s) must be amenable for percutaneous coronary intervention
- General
Exclusion
- The patient has a known hypersensitivity or contraindication to any of the following medications (heparin, aspirin, clopidogrel, sirolimus, everolimus, Contrast media
- Systemic (intravenous) Sirolimus, everolimus use within 12 months.
- Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study.
- History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions.
- Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months.
- Current known current platelet count \<100,000 cells/mm3 or Hgb \<10 g/dL.
- An elective surgical procedure is planned that would necessitate interruption of clopidogrel during the first 12 months post enrollment.
- 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).
- Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
- Patients who have received any stent implantation in the target vessel prior to enrollment.
- Patients with LVEF\<25% or those with cardiogenic shock
- Patients with myocardial infarction within 72 hours
- Creatinine level ≥ 3.0mg/dL or dependence on dialysis.
- Severe hepatic dysfunction (AST and ALT: 3 times upper normal reference values).
- Angiographic Exclusion Criteria
- Patients with significant left main coronary artery stenosis
- Patients who's target lesion has in-stent restenosis at the stented segment of drug-eluting stents or bare metal stents
- Target lesions with chronic total occlusion
- True bifurcation lesions requiring two stents
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2014
Estimated Enrollment :
1466 Patients enrolled
Trial Details
Trial ID
NCT00698607
Start Date
June 1 2008
End Date
April 1 2014
Last Update
June 29 2010
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Seoul National University Hospital
Seoul, 28 Yongon Dong, Jongro Gu, South Korea, 110-744