The Efficacies of The New Paclitaxel-Eluting CoroflexTM Please Stent in Percutaneous Coronary Intervention

This is an interventional treatment trial for Coronary Artery Disease Read More

Inclusion Criteria

• 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 CoroflexTM Please stent and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.
  3. Subject must have coronary artery stenosis (>50% by visual estimate) with evidence of myocardial ischemia (e.g., stable, unstable angina, myocardial infarction, silent ischemia, positive functional study or a reversible changes in the electrocardiogram (ECG) consistent with ischemia.) or Subject must have significant coronary artery stenosis (>70% by visual estimate)

• Angiographic Inclusion Criteria

  1. Target lesion(s) must be located in a native coronary artery with visually estimated diameter of ≥ 2.5 mm and ≤ 4.0 mm.
  2. Target lesion(s) must be amenable for percutaneous coronary intervention

Exclusion Criteria

• General Exclusion Criteria

  1. The patient has a known hypersensitivity or contraindication to any of the following medications:

     • Heparin
     • Aspirin
     • Both Clopidogrel and Ticlopidine
     • Paclitaxel
     • Stainless steel
     • Contrast media(*) (*)Patients with documented sensitivity to contrast media which can be effectively pre-medicated with steroids and diphenhydramine [e.g. rash] may be enrolled. Those with true anaphylaxis to prior contrast media, however, should not be enrolled.
  2. Systemic (intravenous) Paclitaxel 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. An elective surgical procedure is planned that would necessitate interruption of thienopyridines during the first 6 months post enrollment.
  7. 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).
  8. Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
  9. Patients with LVEF<25% or those with cardiogenic shock
  10. Patients with acute ST elevation myocardial infarction who requires primary PCI
  11. Patients with acute ST elevation myocardial infarction within 48hrs
  12. Creatinine level ≥ 3.0mg/dL or dependence on dialysis.

• Angiographic Exclusion Criteria

  1. Patients with significant left main stem stenosis which requires revascularization therapy
  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 bifurcating disease which require side branch stenting